AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  8B PORCELAIN BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22G LIGHT GOLDEN- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  37S MEDIUM-TAN SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  37B MEDIUM-TAN BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  39N MEDIUM-TAN NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  42G TAN GOLDEN- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  42N TAN NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  47G TAN-DEEP GOLDEN- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  48N TAN-DEEP NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  51G DEEP GOLDEN- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  51N DEEP NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  56G RICH GOLDEN- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  58N RICH NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  57S RICH SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  60H MAHOGANY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  12S FAIR SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  12B FAIR BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  13N IVORY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  16N FAIR-LIGHT NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  16B FAIR-LIGHT BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  16H FAIR-LIGHT HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22S LIGHT SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22N LIGHT NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22B LIGHT BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  27S LIGHT-MEDIUM SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  27N LIGHT-MEDIUM NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  29B LIGHT-MEDIUM BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  29H LIGHT-MEDIUM HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  35S MEDIUM SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  35N MEDIUM NEUTRAL- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  35B MEDIUM BEIGE- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  35H MEDIUM HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  36H MEDIUM-TAN HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  40H TAN HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  44S TAN SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  46S TAN-DEEP SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  47H TAN-DEEP HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  51S DEEP SAND- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  53H DEEP HONEY- titanium dioxide and zinc oxide liquid 
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  57H RICH HONEY- titanium dioxide and zinc oxide liquid 
Tarte, Inc

----------

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

Cyclopentasiloxane, water, octyldodecyl neopentanoate, butylene glycol, dimethicone crosspolymer, PEG/PPG-18/18 dimethicone, cetyl PEG/PPG-10/1 dimethicone, polyglyceryl-4 isostearate, mica, aluminum hydroxide, stearic acid, dimethicone, hexyl laurate, silica, phenoxyethanol, caprylyl glycol, sodium dehydroacetate, phytantriol, triethoxycaprylylsilane, nylon-12, sodium chloride, nylon-12 fluorescent brightener 230 salt, octyldodecanol, hexylene glycol, lysine, tocopherol, tetrahexyldecyl ascorbate, methicone, kaolin, magnesium chloride, potassium chloride, zinc chloride, potassium sorbate, polyvinylalcohol crosspolymer, sodium hyaluronate, iron oxides. MX111FL000401.

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 8B Porcelain Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 8B Porcelain Beige

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22G Light Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22G Light Golden

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 37S Medium-Tan Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 37S Medium-Tan Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 37B Medium-Tan Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 37B Medium-Tan Beige

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 39N Medium-Tan Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 39N Medium-Tan Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 42G Tan Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 42G Tan Golden

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 42N Tan Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 42N Tan Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 47G Tan-Deep Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 47G Tan-Deep Golden

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 48N Tan-Deep Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 48N Tan-Deep Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51G Deep Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51G Deep Golden

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51N Deep Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51N Deep Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 56G Rich Golden

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 56G Rich Golden

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 58N Rich Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 58N Rich Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 57S Rich Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 57S Rich Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 60H Mahogany

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 60H Mahogany

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 12S Fair Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 12S Fair Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 12B Fair Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 12B Fair Beige

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 13N Ivory

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 13N Ivory

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16N Fair-Light Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16N Fair-Light Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16B Fair-Light Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16B Fair-Light Beige

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16H Fair-Light Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 16H Fair-Light Honey

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22S Light Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22S Light Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22N Light Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22N Light Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22B Light Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 22B Light Beige

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 27S Light-Medium Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 27S Light-Medium Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 27N Light-Medium Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 27N Light-Medium Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 29B Light-Medium Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 29B Light-Medium Beige

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 29H Light-Medium Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 29H Light-Medium Honey

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35S Medium Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35S Medium Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35N Medium Neutral

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35N Medium Neutral

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35B Medium Beige

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35B Medium Beige

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35H Medium Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 35H Medium Honey

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 36H Medium-Tan Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 36H Medium-Tan Honey

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 40H Tan Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 40H Tan Honey

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 44S Tan Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 44S Tan Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 46S Tan-Deep Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 46S Tan-Deep Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 47H Tan-Deep Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 47H Tan-Deep Honey

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51S Deep Sand

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 51S Deep Sand

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 53H Deep Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 53H Deep Honey

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 57H Rich Honey

tarte
high-performance naturals™

Amazonian clay
full coverage foundation
Broad Spectrum
SPF 15 Sunscreen

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 57H Rich Honey
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   8B PORCELAIN BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-127
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-127-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22G LIGHT GOLDEN
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-128
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-128-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   37S MEDIUM-TAN SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-129
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-129-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   37B MEDIUM-TAN BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-130
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-130-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   39N MEDIUM-TAN NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-131
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-131-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   42G TAN GOLDEN
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-132
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-132-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   42N TAN NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-133
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-133-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   47G TAN-DEEP GOLDEN
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-134
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-134-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   48N TAN-DEEP NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-135
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-135-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   51G DEEP GOLDEN
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-136
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-136-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   51N DEEP NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-137
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-137-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   56G RICH GOLDEN
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-138
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-138-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   58N RICH NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-139
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-139-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   57S RICH SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-140
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-140-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   60H MAHOGANY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-141
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-141-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   12S FAIR SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-142
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-142-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   12B FAIR BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-143
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-143-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   13N IVORY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-144
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-144-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   16N FAIR-LIGHT NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-145
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-145-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   16B FAIR-LIGHT BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-146
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-146-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   16H FAIR-LIGHT HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-147
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-147-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22S LIGHT SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-148
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-148-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22N LIGHT NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-149
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-149-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   22B LIGHT BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-150
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-150-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   27S LIGHT-MEDIUM SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-151
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-151-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   27N LIGHT-MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-152
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-152-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   29B LIGHT-MEDIUM BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-153
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-153-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   29H LIGHT-MEDIUM HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-154
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-154-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35S MEDIUM SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-155
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-155-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35N MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-156
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-156-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35B MEDIUM BEIGE
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-157
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-157-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   35H MEDIUM HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-158
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-158-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   36H MEDIUM-TAN HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-159
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-159-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   40H TAN HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-160
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-160-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   44S TAN SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-161
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-161-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   46S TAN-DEEP SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-162
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-162-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   47H TAN-DEEP HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-163
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-163-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   51S DEEP SAND
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-164
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-164-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   53H DEEP HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-165
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-165-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN   57H RICH HONEY
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-166
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)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51060-166-011 in 1 CARTON11/01/201812/31/2024
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 drugM02011/01/201812/31/2024
Labeler - Tarte, Inc (027905186)

Revised: 12/2024
Document Id: cb239aeb-5281-4534-a4ba-8fa95405e0fd
Set id: 737f9b1b-90ae-49bc-89ae-09e3caf3afd5
Version: 4
Effective Time: 20241223
 
Tarte, Inc