Label: ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION- titanium dioxide powder

  • 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 November 17, 2010

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE21.25 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52664-010-0110 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2010
    Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture
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