AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN IVORY- titanium dioxide and zinc oxide cream AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHT- titanium dioxide and zinc oxide cream AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHT-MEDIUM- titanium dioxide and zinc oxide cream AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN MEDIUM- titanium dioxide and zinc oxide cream AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN MEDIUM-TAN- titanium dioxide and zinc oxide cream AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN TAN- titanium dioxide and zinc oxide cream AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN TAN-DEEP- titanium dioxide and zinc oxide cream

Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Mana Products, INC, MANA Products,INC, MANA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 5%	Sunscreen
Zinc Oxide 5%	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, PEG/PPG-18/18 dimethicone, octyldodecyl neopentanoate, glycerin, dimethicone, aluminum hydroxide, stearic acid, phenoxyethanol, mica, boron nitride, sodium dehydroacetate, caprylyl glycol, sodium chloride, phytantriol, kaolin, magnesium ascorbyl phosphate, palmitic acid, dextrin palmitate, sodium hyaluronate, hexylene glycol, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, methicone, butylene glycol, triethoxycaprylylsilane, calcium sodium phosphosilicate, saccharum officinarum (sugar cane) extract, pyrus malus (apple) fruit extract, citrus limon (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, camellia oleifera leaf extract, panax ginseng root extract, ginkgo biloba leaf extract, anthemis nobilis flower extract, iron oxides.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - ivory

tarte
high-performance naturals™

Amazonian clay
BB tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - light

tarte
high-performance naturals™

Amazonian clay
BB tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - light-medium

tarte
high-performance naturals™

Amazonian clay
BB tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - medium

tarte
high-performance naturals™

Amazonian clay
BB tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - medium-tan

tarte
high-performance naturals™

Amazonian clay
BB tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - tan

tarte
high-performance naturals™

Amazonian clay
BB tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - tan-deep

tarte
high-performance naturals™

Amazonian clay
BB tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN  IVORY
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYTANTRIOL (UNII: 8LVI07A72W)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUGARCANE (UNII: 81H2R5AOH3)
APPLE (UNII: B423VGH5S9)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-900-02	1 in 1 CARTON	05/01/2004
1	NDC: 59735-900-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59735-900-04	1 in 1 CARTON	05/01/2004
2	NDC: 59735-900-03	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 Drug	M020	05/01/2004

AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN  LIGHT
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYTANTRIOL (UNII: 8LVI07A72W)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUGARCANE (UNII: 81H2R5AOH3)
APPLE (UNII: B423VGH5S9)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-901-02	1 in 1 CARTON	05/01/2004
1	NDC: 59735-901-01	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 Drug	M020	05/01/2004

AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN  LIGHT-MEDIUM
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYTANTRIOL (UNII: 8LVI07A72W)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUGARCANE (UNII: 81H2R5AOH3)
APPLE (UNII: B423VGH5S9)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-902-02	1 in 1 CARTON	05/01/2004
1	NDC: 59735-902-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59735-902-04	1 in 1 CARTON	05/01/2004
2	NDC: 59735-902-03	50 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 59735-902-06	1 in 1 CARTON	05/01/2004
3	NDC: 59735-902-05	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 Drug	M020	05/01/2004

AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN  MEDIUM
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYTANTRIOL (UNII: 8LVI07A72W)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUGARCANE (UNII: 81H2R5AOH3)
APPLE (UNII: B423VGH5S9)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-903-02	1 in 1 CARTON	05/01/2004
1	NDC: 59735-903-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59735-903-04	1 in 1 CARTON	05/01/2004
2	NDC: 59735-903-03	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 Drug	M020	05/01/2004

AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN  MEDIUM-TAN
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYTANTRIOL (UNII: 8LVI07A72W)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUGARCANE (UNII: 81H2R5AOH3)
APPLE (UNII: B423VGH5S9)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-904-02	1 in 1 CARTON	05/01/2004
1	NDC: 59735-904-01	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 Drug	M020	05/01/2004

AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN  TAN
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYTANTRIOL (UNII: 8LVI07A72W)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUGARCANE (UNII: 81H2R5AOH3)
APPLE (UNII: B423VGH5S9)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-905-02	1 in 1 CARTON	05/01/2004
1	NDC: 59735-905-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59735-905-04	1 in 1 CARTON	05/01/2004
2	NDC: 59735-905-03	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 Drug	M020	05/01/2004

AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN  TAN-DEEP
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-920
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHYTANTRIOL (UNII: 8LVI07A72W)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUGARCANE (UNII: 81H2R5AOH3)
APPLE (UNII: B423VGH5S9)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-920-02	1 in 1 CARTON	05/01/2004
1	NDC: 59735-920-01	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 Drug	M020	05/01/2004

Labeler - Mana Products, INC (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products,INC		032870270	manufacture(59735-901, 59735-900, 59735-902, 59735-903, 59735-904, 59735-905, 59735-920)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	manufacture(59735-900, 59735-901, 59735-902, 59735-903, 59735-904, 59735-905, 59735-920)