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 zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  FAIR- LIGHT HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  IVORY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT-MEDIUM BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT-MEDIUM HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT-MEDIUM SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  MEDIUM HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  MEDIUM SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  MEDIUM-TAN HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  TAN HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  TAN-DEEP SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  DEEP HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  FAIRLY-LIGHT BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  FAIRLY-LIGHT NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  LIGHT MEDIUM NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  RICH HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN 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 
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 Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen

Drug Facts

Active ingredientsPurpose
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.

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 - Deep Sand

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 Beige

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 Sand

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 - Fair-Light Honey

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 - Ivory

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 Beige

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 Neutral

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 Sand

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 Beige

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 Honey

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 - Light-Medium Sand

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 Honey

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 Sand

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 - Medium-Tan Honey

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 Honey

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 - Tan-Deep Sand

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 - Deep Honey

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 Beige

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 - Fairly Light Neutral

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 - Light-Medium Neutral

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 - Rich Honey

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 - Tan Sand

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 Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Beige
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   DEEP SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-047
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-047-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   FAIR BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-048
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-048-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   FAIR SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-049
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-049-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   FAIR- LIGHT HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-050
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-050-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   IVORY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-051
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-051-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-052
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-052-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-053
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-053-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-054
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-054-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT-MEDIUM BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-055
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-055-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT-MEDIUM HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-056
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-056-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT-MEDIUM SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-057
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-057-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   MEDIUM HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-058
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-058-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   MEDIUM SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-059
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-059-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   MEDIUM-TAN HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-060
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-060-011 in 1 CARTON07/01/201311/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201311/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   TAN HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-061
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-061-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   TAN-DEEP SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-062
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-062-011 in 1 CARTON03/01/201111/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/201111/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   DEEP HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-117
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-117-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   FAIRLY-LIGHT BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-118
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-118-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   FAIRLY-LIGHT NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-119
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-119-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   LIGHT MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-120
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-120-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   RICH HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-121
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-121-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   TAN SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-122
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-122-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-124
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-124-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   MEDIUM BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-123
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 Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-123-011 in 1 CARTON07/01/201511/01/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201511/01/2018
Labeler - Tarte, Inc (027905186)

Revised: 12/2020
Document Id: e5f5f427-6a3e-4317-a9b1-59822435de0d
Set id: 2005f463-cc3f-4fe0-9ab1-e2a2964481bc
Version: 3
Effective Time: 20201201
 
Tarte, Inc