AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  FAIR- titanium dioxide and zinc oxide liquid 
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT- titanium dioxide and zinc oxide liquid 
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  MEDIUM- titanium dioxide and zinc oxide liquid 
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  TAN- titanium dioxide and zinc oxide liquid 
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  DEEP- titanium dioxide and zinc oxide liquid 
Tarte, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 6%Sunscreen
Zinc Oxide 4%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

  • Shake before use.
  • 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, glycerin, isododecane, cyclopentasiloxane, phenyl trimethicone, nylon-12, dipropylene glycol, caprylic/capric triglyceride, cyclohexasiloxane, aluminum starch octenylsuccinate, SD alcohol 40-B, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, magnesium sulfate, silica, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, talc, sorbitan isostearate, stearalkonium hectorite, polyglyceryl-4 isostearate, hexyl laurate, aluminum hydroxide, stearic acid, caprylyl glycol, propylene carbonate, dimethicone, hydrogen dimethicone, phenoxyethanol, triethoxycaprylylsilane, tocopheryl acetate, 1,2-hexanediol, kaolin, magnesium aluminum silicate, mica, montmorilloniate, iron oxides.

Dist. by tarte™, Inc. NY 10018.

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton - Fair

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 - 20 mL Bottle Carton - Light

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 - 20 mL Bottle Carton - Medium

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 - 20 mL Bottle Carton - Tan

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 - 20 mL Bottle Carton - Deep

tarte
high-performance naturals™

CC

Amazonian colored clay liquid foundation
Broad Spectrum
SPF 15 Sunscreen

Principal Display Panel - 20 mL Bottle Carton - Deep
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   FAIR
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-063-011 in 1 CARTON02/01/201403/06/2016
120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201403/06/2016
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-064-011 in 1 CARTON02/01/201403/06/2016
120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201403/06/2016
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   MEDIUM
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-065-011 in 1 CARTON02/01/201403/06/2016
120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201403/06/2016
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   TAN
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-066-011 in 1 CARTON02/01/201403/06/2016
120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201403/06/2016
AMAZONIAN COLORED CLAY FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   DEEP
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-067-011 in 1 CARTON02/01/201403/06/2016
120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201403/06/2016
Labeler - Tarte, Inc. (027905186)

Revised: 12/2018
 
Tarte, Inc.