Label: ELF PERSONAL BLEND FOUNDATION SPF 15- 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 May 1, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Zinc Oxide: 15%

    Titanium Dioxide: 10%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    Help prevent Sunburn

  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When Using This Product:

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water

  • 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:

    Move the dial opening to desired color and shake the Personal Blend Foundation SPF 15 back and forth to get excess powder loose onto the tray. Gently glide over the powder with a brush to grab the powder, bring your brush to the cap to work in the powder to the brush, then tap off any excess. Apply to the areas of the face that need coverage by working into the skin in a circular motion. When not in use, move the dial opening in between two colors so the dial opening is closed.

  • STORAGE AND HANDLING

    Other Imformation:

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

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Mica, Fragrance, Bismuth Oxychloride, Tocopheryl Acetate, Boron Nitride

    May contain:

    Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Ultramarine Blue (CI 77007)

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    ELF PERSONAL BLEND FOUNDATION SPF 15 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76166-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76166-001-012.8 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2011
    Labeler - Shanghai Justking Enterprise Co. Ltd. (421267459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Justking Enterprise Co. Ltd.421267459manufacture
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