Label: 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 .......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

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    51060-127-01, 51060-128-01, 51060-129-01, 51060-130-01, view more
    51060-131-01, 51060-132-01, 51060-133-01, 51060-134-01, 51060-135-01, 51060-136-01, 51060-137-01, 51060-138-01, 51060-139-01, 51060-140-01, 51060-141-01, 51060-142-01, 51060-143-01, 51060-144-01, 51060-145-01, 51060-146-01, 51060-147-01, 51060-148-01, 51060-149-01, 51060-150-01, 51060-151-01, 51060-152-01, 51060-153-01, 51060-154-01, 51060-155-01, 51060-156-01, 51060-157-01, 51060-158-01, 51060-159-01, 51060-160-01, 51060-161-01, 51060-162-01, 51060-163-01, 51060-164-01, 51060-165-01, 51060-166-01
  • Packager: Tarte, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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

Drug Label Information

Updated December 17, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 6%Sunscreen
    Zinc Oxide 3%Sunscreen
  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only.

    Stop use and ask doctor if rash occurs.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor.
    • Optional: apply to all skin exposed to the sun.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      Limit time in the sun, especially from 10 a.m.-2 p.m.
      Wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
    • You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
  • Inactive ingredients

    Water, cyclopentasiloxane, octyldodecyl neopentanoate butylene glycol, polyglyceryl-4 isostearate, dimethicone crosspolymer, PEG/PPG-18/18 dimethicone, mica, dimethicone, silica, phenoxyethanol, cetyl PEG/PPG-10/1 dimethicone, stearic acid, aluminum hydroxide, sodium dehydroacetate, caprylyl glycol, phytantriol, hexyl laurate, triethoxycaprylylsilane, sodium chloride, hexylene glycol, lysine, tocopherol, tetrahexyldecyl ascorbate, nylon-12 fluorescent brightener 230 salt, polyvinylalcohol crosspolymer, kaolin, magnesium chloride, potassium chloride, zinc chloride, sodium hyaluronate, potassium sorbate, iron oxides. MX111FL000361.

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    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 CARTON11/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    Labeler - Tarte, Inc (027905186)