NDC Code(s) : 51060-040-01, 51060-041-01, 51060-042-01, 51060-043-01, 51060-044-01, 51060-045-01, 51060-046-01
Packager : Tarte, Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide50 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
1NDC:51060-040-011 in 1 CARTON 05/01/2004
150 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 Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-041
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide50 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
1NDC:51060-041-011 in 1 CARTON 05/01/2004
150 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 Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-042
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide50 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
1NDC:51060-042-011 in 1 CARTON 05/01/2004
150 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 Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-043
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide50 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
1NDC:51060-043-011 in 1 CARTON 05/01/2004
150 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 Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-044
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide50 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
1NDC:51060-044-011 in 1 CARTON 05/01/2004
150 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 Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-045
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide50 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
1NDC:51060-045-011 in 1 CARTON 05/01/2004
150 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 Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-046
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide50 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
1NDC:51060-046-011 in 1 CARTON 05/01/2004
150 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 - Tarte, Inc(027905186)

PRINCIPAL DISPLAY PANEL

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 - ivory

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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