AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 8B PORCELAIN BEIGE- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 22G LIGHT GOLDEN- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 37S MEDIUM-TAN SAND .......CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 51S DEEP SAND- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 53H DEEP HONEY- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 57H RICH HONEY- titanium dioxide and zinc oxide liquid

Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Tarte, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 6%	Sunscreen
Zinc Oxide 3%	Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Stop use and ask doctor if rash occurs.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: Ask a doctor.
• Optional: apply to all skin exposed to the sun.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • – Limit time in the sun, especially from 10 a.m.-2 p.m.
  • – Wear long-sleeved shirts, pants, hats and sunglasses

Other information

• Protect the product in this container from excessive heat and direct sunlight.
• You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.

Inactive ingredients

Water, cyclopentasiloxane, octyldodecyl neopentanoate butylene glycol, polyglyceryl-4 isostearate, dimethicone crosspolymer, PEG/PPG-18/18 dimethicone, mica, dimethicone, silica, phenoxyethanol, cetyl PEG/PPG-10/1 dimethicone, stearic acid, aluminum hydroxide, sodium dehydroacetate, caprylyl glycol, phytantriol, hexyl laurate, triethoxycaprylylsilane, sodium chloride, hexylene glycol, lysine, tocopherol, tetrahexyldecyl ascorbate, nylon-12 fluorescent brightener 230 salt, polyvinylalcohol crosspolymer, kaolin, magnesium chloride, potassium chloride, zinc chloride, sodium hyaluronate, potassium sorbate, iron oxides. MX111FL000361.

SPL UNCLASSIFIED SECTION

Dist. by tarte, Inc. New
York, NY 10018.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 8B Porcelain Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22G Light Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 37S Medium-Tan Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 37B Medium-Tan Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 39N Medium-Tan Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 42G Tan Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 42N Tan Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 47G Tan-Deep Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 48N Tan-Deep Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51G Deep Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51N Deep Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 56G Rich Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 58N Rich Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 57S Rich Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 60H Mahogany

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 12S Fair Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 12B Fair Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 13N Ivory

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16N Fair-light Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16B Fair-light Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16H Fair-light Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22S Light Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22N Light Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22B Light Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 27S Light-Medium Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 27N Light-medium Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 29B Light-medium Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 29H Light-medium Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35S Medium Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35N Medium Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35B Medium Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35H Medium Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 36H Medium-tan Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 40H Tan Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 44S Tan Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 46S Tan-deep Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 47H Tan-deep Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51S Deep Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 53H Deep Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 57H Rich Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

INGREDIENTS AND APPEARANCE

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   8B PORCELAIN BEIGE
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-127-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22G LIGHT GOLDEN
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-128-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   37S MEDIUM-TAN SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-129-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   37B MEDIUM-TAN BEIGE
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-130-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   39N MEDIUM-TAN NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-131-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   42G TAN GOLDEN
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-132-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   42N TAN NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-133-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   47G TAN-DEEP GOLDEN
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-134-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   48N TAN-DEEP NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-135-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   51G DEEP GOLDEN
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-136
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-136-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   51N DEEP NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-137-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   56G RICH GOLDEN
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-138-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   58N RICH NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-139-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   57S RICH SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-140-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   60H MAHOGANY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHYTANTRIOL (UNII: 8LVI07A72W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-141-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   12S FAIR SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-142
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-142-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   12B FAIR BEIGE
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-143-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   13N IVORY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-144-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   16N FAIR-LIGHT NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-145-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   16B FAIR-LIGHT BEIGE
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-146-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   16H FAIR-LIGHT HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-147
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-147-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22S LIGHT SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-148
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-148-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22N LIGHT NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-149-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22B LIGHT BEIGE
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-150-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   27S LIGHT-MEDIUM SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-151-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   27N LIGHT-MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-152-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   29B LIGHT-MEDIUM BEIGE
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-153-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   29H LIGHT-MEDIUM HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-154-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35S MEDIUM SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-155-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35N MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-156-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35B MEDIUM BEIGE
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-157-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35H MEDIUM HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-158-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   36H MEDIUM-TAN HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-159-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   40H TAN HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-160-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   44S TAN SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-161-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   46S TAN-DEEP SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-162-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   47H TAN-DEEP HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-163-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   51S DEEP SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-164
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-164-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   53H DEEP HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-165-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   57H RICH HONEY
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-166-01	1 in 1 CARTON	11/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018

Labeler - Tarte, Inc (027905186)