Home > Drugs A-Z > ELF SPF 45 Sunscreen UVA/UVB Protection

ELF SPF 45 Sunscreen UVA/UVB Protection (J. A. Cosmetics U.S. INC)

Available Formats

Dosage Form Package Information Links
POWDER 10 g in 1 BOTTLE (76354-016-01) Label Information

Complete ELF SPF 45 Sunscreen UVA/UVB Protection Information

  • ACTIVE INGREDIENT

    Active Ingredient:

    Titanium Dioxide: 23.3%

    Zinc Oxide: 18.7%


  • PURPOSE

    Purpose:

    Sunscreen


  • INDICATIONS & USAGE

    Uses:

    Help prevent sunburns


  • WARNINGS

    Warning:

    For external use only

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer and skin aging.


  • 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)

    Protect this product in its container away from excessive heat and direct sun


  • INACTIVE INGREDIENT

    Inactive Ingredient:

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

    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:76354-016
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23.3 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.7 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)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76354-016-01 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 10/22/2011
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Registrant - J. A. Cosmetics U.S. INC (186705047)
    Establishment
    Name Address ID/FEI Business Operations
    Shanghai J. A. Cosmetics Trading CO., LTD. 421280183 manufacture