Label: SHEER FACE- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 28, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 15%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn

    • Retains SPF after 80 minutes of swimming or sweating • 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.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop using and ask a doctor

    if a rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center right away.

  • Directions

    • Apply liberally and spread evenly 15 minutes before sun exposure and as needed. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 of 15 or higher and other sun protection measures including • limit time in the sun, especially from 10 am- 2pm • wear long-sleeved shirts, pants, hats, and sunglasses




    Sun Protection Measures.

  • Inactive Ingredients

    Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bixa Orellana (Annatto) Extract, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

  • Other Information

    Protect the product from excessive heat and direct sun.

  • Package Labeling:

    Label5Label6

  • INGREDIENTS AND APPEARANCE
    SHEER FACE 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75796-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    WATERMELON (UNII: 231473QB6R)  
    CARROT (UNII: L56Z1JK48B)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75796-003-0188 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2020
    Labeler - Make2Give LLC (023910159)