Label: HEALTHY MAKEUP CREAM-TO-POWDER FOUNDATION- titanium dioxide cream

  • 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 June 9, 2010

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  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn.

  • DOSAGE & ADMINISTRATION

    Directions: Apply evenly before sun exposure as needed. Children under 6 months of age: Ask a healthcare practitioner.

  • WARNINGS

    WARNINGS: For external use only.

    When using this product, keep out of eyes. If contact occurs, rinse thoroughly with water to remove.

    Stop use and ask a health care practitioner if rash or irritation develops or lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • ACTIVE INGREDIENT

    Active/Medicinal Ingredient: TITANIUM DIOXIDE 8.5%

  • INACTIVE INGREDIENT

    Inactive/Non Medicinal Ingredients:

         DIMETHICONE
         NEOPENTYL GLYCOL DICAPRATE
         PHENYL TRIMETHICONE
         POLYMETHYL METHACRYLATE
         OZOKERITE
         NYLON-12
         MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE
         PHYTOL
         OLEA EUROPAEA (OLIVE) LEAF EXTRACT
         PYRUS MALUS (APPLE) ROOT EXTRACT
         GLYCINE SOJA (SOYBEAN) OIL
         SORBITAN SESQUIOLEATE
         PUNICA GRANATUM FRUIT JUICE
         RETINOXYTRIMETHYLSILANE
         TOCOPHERYL ACETATE
         RETINYL PALMITATE
         ASCORBYL PALMITATE
         TOCOPHEROL
         BARIUM SULFATE
         WATER/EAU
         TRIETHOXYCAPRYLYLSILANE
         METHICONE
         METHYLPARABEN

    MAY CONTAIN:
           TITANIUM DIOXIDE/CI 77891
           MICA/CI 77019
           IRON OXIDES

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of cartonimage of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    HEALTHY MAKEUP  CREAM-TO-POWDER FOUNDATION
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE765 mg  in 9 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0214-21 in 1 CARTON
    1NDC:10096-0214-19 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/09/2010
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.001807106manufacture
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