NDC Code(s) : 51060-063-01, 51060-064-01, 51060-065-01, 51060-066-01, 51060-067-01
Packager : Tarte, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-063
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 Dioxide60 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Isododecane(UNII: A8289P68Y2)
cyclomethicone 5(UNII: 0THT5PCI0R)
phenyl trimethicone(UNII: DR0K5NOJ4R)
nylon-12(UNII: 446U8J075B)
dipropylene glycol(UNII: E107L85C40)
medium-chain triglycerides(UNII: C9H2L21V7U)
cyclomethicone 6(UNII: XHK3U310BA)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
butylene glycol(UNII: 3XUS85K0RA)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
silicon dioxide(UNII: ETJ7Z6XBU4)
PEG-9 polydimethylsiloxyethyl dimethicone(UNII: TYP81E471F)
aluminum oxide(UNII: LMI26O6933)
talc(UNII: 7SEV7J4R1U)
sorbitan isostearate(UNII: 01S2G2C1E4)
stearalkonium hectorite(UNII: OLX698AH5P)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
aluminum hydroxide(UNII: 5QB0T2IUN0)
stearic acid(UNII: 4ELV7Z65AP)
caprylyl glycol(UNII: 00YIU5438U)
propylene carbonate(UNII: 8D08K3S51E)
dimethicone(UNII: 92RU3N3Y1O)
phenoxyethanol(UNII: HIE492ZZ3T)
triethoxycaprylylsilane(UNII: LDC331P08E)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
1,2-hexanediol(UNII: TR046Y3K1G)
kaolin(UNII: 24H4NWX5CO)
magnesium aluminum silicate(UNII: 6M3P64V0NC)
mica(UNII: V8A1AW0880)
MONTMORILLONITE(UNII: A585MN1H2L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-063-011 in 1 CARTON 02/01/2014
120 mL in 1 BOTTLE 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 02/01/2014
Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-064
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 Dioxide60 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Isododecane(UNII: A8289P68Y2)
cyclomethicone 5(UNII: 0THT5PCI0R)
phenyl trimethicone(UNII: DR0K5NOJ4R)
nylon-12(UNII: 446U8J075B)
dipropylene glycol(UNII: E107L85C40)
medium-chain triglycerides(UNII: C9H2L21V7U)
cyclomethicone 6(UNII: XHK3U310BA)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
butylene glycol(UNII: 3XUS85K0RA)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
silicon dioxide(UNII: ETJ7Z6XBU4)
PEG-9 polydimethylsiloxyethyl dimethicone(UNII: TYP81E471F)
aluminum oxide(UNII: LMI26O6933)
talc(UNII: 7SEV7J4R1U)
sorbitan isostearate(UNII: 01S2G2C1E4)
stearalkonium hectorite(UNII: OLX698AH5P)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
aluminum hydroxide(UNII: 5QB0T2IUN0)
stearic acid(UNII: 4ELV7Z65AP)
caprylyl glycol(UNII: 00YIU5438U)
propylene carbonate(UNII: 8D08K3S51E)
dimethicone(UNII: 92RU3N3Y1O)
phenoxyethanol(UNII: HIE492ZZ3T)
triethoxycaprylylsilane(UNII: LDC331P08E)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
1,2-hexanediol(UNII: TR046Y3K1G)
kaolin(UNII: 24H4NWX5CO)
magnesium aluminum silicate(UNII: 6M3P64V0NC)
mica(UNII: V8A1AW0880)
MONTMORILLONITE(UNII: A585MN1H2L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-064-011 in 1 CARTON 02/01/2014
120 mL in 1 BOTTLE 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 02/01/2014
Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-065
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 Dioxide60 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Isododecane(UNII: A8289P68Y2)
cyclomethicone 5(UNII: 0THT5PCI0R)
phenyl trimethicone(UNII: DR0K5NOJ4R)
nylon-12(UNII: 446U8J075B)
dipropylene glycol(UNII: E107L85C40)
medium-chain triglycerides(UNII: C9H2L21V7U)
cyclomethicone 6(UNII: XHK3U310BA)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
butylene glycol(UNII: 3XUS85K0RA)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
silicon dioxide(UNII: ETJ7Z6XBU4)
PEG-9 polydimethylsiloxyethyl dimethicone(UNII: TYP81E471F)
aluminum oxide(UNII: LMI26O6933)
talc(UNII: 7SEV7J4R1U)
sorbitan isostearate(UNII: 01S2G2C1E4)
stearalkonium hectorite(UNII: OLX698AH5P)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
aluminum hydroxide(UNII: 5QB0T2IUN0)
stearic acid(UNII: 4ELV7Z65AP)
caprylyl glycol(UNII: 00YIU5438U)
propylene carbonate(UNII: 8D08K3S51E)
dimethicone(UNII: 92RU3N3Y1O)
phenoxyethanol(UNII: HIE492ZZ3T)
triethoxycaprylylsilane(UNII: LDC331P08E)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
1,2-hexanediol(UNII: TR046Y3K1G)
kaolin(UNII: 24H4NWX5CO)
magnesium aluminum silicate(UNII: 6M3P64V0NC)
mica(UNII: V8A1AW0880)
MONTMORILLONITE(UNII: A585MN1H2L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-065-011 in 1 CARTON 02/01/2014
120 mL in 1 BOTTLE 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 02/01/2014
Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-066
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 Dioxide60 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Isododecane(UNII: A8289P68Y2)
cyclomethicone 5(UNII: 0THT5PCI0R)
phenyl trimethicone(UNII: DR0K5NOJ4R)
nylon-12(UNII: 446U8J075B)
dipropylene glycol(UNII: E107L85C40)
medium-chain triglycerides(UNII: C9H2L21V7U)
cyclomethicone 6(UNII: XHK3U310BA)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
butylene glycol(UNII: 3XUS85K0RA)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
silicon dioxide(UNII: ETJ7Z6XBU4)
PEG-9 polydimethylsiloxyethyl dimethicone(UNII: TYP81E471F)
aluminum oxide(UNII: LMI26O6933)
talc(UNII: 7SEV7J4R1U)
sorbitan isostearate(UNII: 01S2G2C1E4)
stearalkonium hectorite(UNII: OLX698AH5P)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
aluminum hydroxide(UNII: 5QB0T2IUN0)
stearic acid(UNII: 4ELV7Z65AP)
caprylyl glycol(UNII: 00YIU5438U)
propylene carbonate(UNII: 8D08K3S51E)
dimethicone(UNII: 92RU3N3Y1O)
phenoxyethanol(UNII: HIE492ZZ3T)
triethoxycaprylylsilane(UNII: LDC331P08E)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
1,2-hexanediol(UNII: TR046Y3K1G)
kaolin(UNII: 24H4NWX5CO)
magnesium aluminum silicate(UNII: 6M3P64V0NC)
mica(UNII: V8A1AW0880)
MONTMORILLONITE(UNII: A585MN1H2L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-066-011 in 1 CARTON 02/01/2014
120 mL in 1 BOTTLE 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 02/01/2014
Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-067
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 Dioxide60 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Isododecane(UNII: A8289P68Y2)
cyclomethicone 5(UNII: 0THT5PCI0R)
phenyl trimethicone(UNII: DR0K5NOJ4R)
nylon-12(UNII: 446U8J075B)
dipropylene glycol(UNII: E107L85C40)
medium-chain triglycerides(UNII: C9H2L21V7U)
cyclomethicone 6(UNII: XHK3U310BA)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
butylene glycol(UNII: 3XUS85K0RA)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
silicon dioxide(UNII: ETJ7Z6XBU4)
PEG-9 polydimethylsiloxyethyl dimethicone(UNII: TYP81E471F)
aluminum oxide(UNII: LMI26O6933)
talc(UNII: 7SEV7J4R1U)
sorbitan isostearate(UNII: 01S2G2C1E4)
stearalkonium hectorite(UNII: OLX698AH5P)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
aluminum hydroxide(UNII: 5QB0T2IUN0)
stearic acid(UNII: 4ELV7Z65AP)
caprylyl glycol(UNII: 00YIU5438U)
propylene carbonate(UNII: 8D08K3S51E)
dimethicone(UNII: 92RU3N3Y1O)
phenoxyethanol(UNII: HIE492ZZ3T)
triethoxycaprylylsilane(UNII: LDC331P08E)
.alpha.-tocopherol acetate(UNII: 9E8X80D2L0)
1,2-hexanediol(UNII: TR046Y3K1G)
kaolin(UNII: 24H4NWX5CO)
magnesium aluminum silicate(UNII: 6M3P64V0NC)
mica(UNII: V8A1AW0880)
MONTMORILLONITE(UNII: A585MN1H2L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-067-011 in 1 CARTON 02/01/2014
120 mL in 1 BOTTLE 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 02/01/2014

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

CC

Amazonian colored clay liquid foundation
Broad Spectrum
SPF 15 Sunscreen

Principal Display Panel - 20 mL Bottle Carton - Fair

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

CC

Amazonian colored clay liquid foundation
Broad Spectrum
SPF 15 Sunscreen

Principal Display Panel - 20 mL Bottle Carton - Light

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

CC

Amazonian colored clay liquid foundation
Broad Spectrum
SPF 15 Sunscreen

Principal Display Panel - 20 mL Bottle Carton - Medium

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

CC

Amazonian colored clay liquid foundation
Broad Spectrum
SPF 15 Sunscreen

Principal Display Panel - 20 mL Bottle Carton - Tan

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

CC

Amazonian colored clay liquid foundation
Broad Spectrum
SPF 15 Sunscreen

Principal Display Panel - 20 mL Bottle Carton - Deep