Label: AVON EXTRALASTING- titanium dioxide, zinc oxide 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 April 22, 2011

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  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn.

  • DOSAGE & ADMINISTRATION

    Directions: Apply evenly before sun exposure and as needed. Reapply
    frequently for SPF benefit. Children under 6 months of age: Ask a health
    care 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 INGREDIENTS: TITANIUM DIOXIDE 7.8%, ZINC OXIDE 6.86%.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS/INGRÉDIENTS INACTIFS: C12-15 ALKYL BENZOATE, NYLON-12,
    TALC, LAUROYL LYSINE, SYNTHETIC FLUORPHLOGOPITE, ALUMINUM HYDROXIDE, DIMETHICONE,
    ZINC STEARATE, CAPRYLYL GLYCOL, ISOBUTYLENE/STYRENE COPOLYMER, PPG-
    12/SMDI COPOLYMER, KAOLIN, TRIETHOXYCAPRYLYLSILANE, CHITOSAN, METHICONE.
    MAY CONTAIN/PEUT CONTENIR: MICA/CI 77019, TITANIUM DIOXIDE/CI 77891, IRON OXIDES.

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    AVON  EXTRALASTING
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.936 g  in 12 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.8232 g  in 12 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0260-21 in 1 CARTON
    1NDC:10096-0260-112 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/22/2011
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture
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