Label: EVERYDAY SHEER COVERAGE LIGHT TINT SPF 20- zinc oxide cream

  • NDC Code(s): 62742-4159-1, 62742-4159-2
  • Packager: Allure Labs Inc
  • Category: HUMAN OTC DRUG LABEL

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 15, 2017

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  • ACTIVE INGREDIENT

    Non Nano Zinc Oxide - 17.7%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Uses: if used as directed with other sun protection measures, this product reduces the risk of cancer, early skin aging and helps prevent sunburn.

  • WARNINGS

    for external use only. if irritation developes, discontinue use and consult physician.

  • DOSAGE & ADMINISTRATION

    Shake well and keep in a cool place. Apply liberally to face, neck and chest before sun exposure. Reapply as needed, and after swimming, perspirin or towel drying. For children under 6 months, consult physicain.

  • INACTIVE INGREDIENT

    Camellia Sinensis (Green and White Tea) Leaf Extract, Glycerin, Crambe Abyssinica (Abyssinian Seed Oil, Caprylic/Capric Triglycerides (from Coconut), Rubus Idaeus (Red Raspberry) Seed Oil, Punica Granatum (Pomegranade) Seed Oil, Brassica Oleracea Italic (Broccoli) Seed Oil, Tocoperol (non-GMO Vitamin E), Acetyl Glucosamine ( from non-GMO corn), Prunus Avium (Sweet Cherry Seed Oil), Silk Powder, Pearl Powder, Sodium Hyaluronate (Hyaluronic Acid), Beta-Glucan, Coffea Arabica (Coffee) Seed Extract, Lecithin, Rosemary Officinalis (Rosemary) Leaf Extract, Xanthan Gum, Potassium Sorbate, Citrus Aurantium Amara (Neroli) FLower Oil, Lavandula Angustifolia (Lavender) Oil, Phenethyl Alcohol, Ethylhexylglycerin, Iron Oxides, Mica, Titanium Dioxide (For Pigment).

  • PRINCIPAL DISPLAY PANEL

    True Botanicals

    Mill Valley, California 94941

    truebotanicals.com

    Sheer Coverage Light Tint SPF 20.jpg

    Sheer Coverage Light Tint SPF 20.jpg

  • INGREDIENTS AND APPEARANCE
    EVERYDAY SHEER COVERAGE LIGHT TINT SPF 20 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION177 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WHITE TEA (UNII: O0M3396E09)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    BROCCOLI SEED OIL (UNII: SY01LVD4G4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4159-21 in 1 CARTON12/15/2017
    1NDC:62742-4159-130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/15/2017
    Labeler - Allure Labs Inc (926831603)
    Registrant - Allure Labs Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs Inc926831603manufacture(62742-4159)
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