AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN DEEP SAND- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR BEIGE- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR SAND (titanium dioxide and zin .......ZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN TAN SAND- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM NEUTRAL- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM BEIGE- 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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Deep Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fair Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fair Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fair-Light Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Ivory

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light-Medium Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light-Medium Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

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

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium-Tan Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Tan Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Tan-Deep Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Deep Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fairly Light Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fairly Light Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light-Medium Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Rich Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Tan Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Beige

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   DEEP SAND
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-047
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-047-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-048
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-048-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-049
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-049-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-050
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-050-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-051
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-051-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-052
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-052-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-053
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-053-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-054
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-054-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-055
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-055-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-056
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-056-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-057
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-057-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-058
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-058-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-059
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-059-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-060
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-060-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-061
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-061-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-062
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-062-01	1 in 1 CARTON	03/01/2011
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	03/01/2011

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-117
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
mica (UNII: V8A1AW0880)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-117-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-118
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-118-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-119
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-119-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-120
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-120-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-121
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-121-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-122
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-122-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-124
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-124-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-123
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)
PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium dehydroacetate (UNII: 8W46YN971G)
phytantriol (UNII: 8LVI07A72W)
hexyl laurate (UNII: 4CG9F9W01Q)
triethoxycaprylylsilane (UNII: LDC331P08E)
nylon-12 (UNII: 446U8J075B)
sodium chloride (UNII: 451W47IQ8X)
kaolin (UNII: 24H4NWX5CO)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-123-01	1 in 1 CARTON	07/01/2015
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	07/01/2015

Labeler - Tarte, Inc (027905186)