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ELF SPF 45 Sunscreen UVA/UVB Protection (Hangzhou Facecare Cosmetics Co., Ltd.)

Available Formats

Dosage Form Package Information Links
POWDER 10 g in 1 BOTTLE (52664-010-01) Label Information

Complete ELF SPF 45 Sunscreen UVA/UVB Protection Information

  • ACTIVE INGREDIENT

    Active Ingredient:

    Titanium Dioxide: 21.25%

    Zinc Oxide: 17%


  • PURPOSE

    Purpose:

    Sunscreen


  • INDICATIONS & USAGE

    Uses:

    Help prevent sunburns

    Higher SPF gives more sunburn protection


  • WARNINGS

    Warning:

    For external use only


  • WHEN USING

    When Using This Product:

    Keep out of eyes. Rinse with water to remove.


  • ASK DOCTOR

    Stop Use and Ask a Doctor if:

    Rash or irritation develops and lasts


  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children:

    If swallowed get medical help or contact a Poison Control Center immediately


  • DOSAGE & ADMINISTRATION

    Directions:

    Apply as needed for 15-20 minutes of sun exposure


  • STORAGE AND HANDLING

    Other Imformation:

    Store at room temperature 15-30C (59-86F)


  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Mica, Silica, Talc, Bismuth Oxychloride, Boron Nitride, Aluminum Hydroxide, Sodium Dehydroacetate, Vitis Vinifera (Grape) Seed Extract, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (VA), Tocopheryl Acetate (VE)

    May contain:

    Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742)


  • PRINCIPAL DISPLAY PANEL

    labelabel


  • INGREDIENTS AND APPEARANCE
    ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION 
    titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52664-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 21.25 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52664-010-01 10 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 12/01/2010
    Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Establishment
    Name Address ID/FEI Business Operations
    Hangzhou Facecare Cosmetics Co., Ltd. 545341856 manufacture