Label: EXTRALASTING CREAM-TO-POWDER FOUNDATION- octinoxate and titanium dioxide cream 

  • NDC Code(s): 10096-0231-1, 10096-0231-2
  • Packager: Avon Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    Octinoxate 6.34%...................................

    Titanium Dioxide 3.00%............................

                                Purpose
    ...................................Sunscreen
    ...................................Sunscreen

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  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn

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  • WARNINGS

    WARNINGS
    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

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

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  • DOSAGE & ADMINISTRATION

    Directions
    • apply liberally 15 minutes before sun exposure
    • children under 6 months of age: ask a doctor
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. – 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

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  • STORAGE AND HANDLING

    Other information
    • protect the product in this container from excessive heat and direct sun

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  • INACTIVE INGREDIENT

    Inactive ingredients: Propylene Glycol Dicaprylate/Dicaprate, Diisopropyl Dimer Dilinoleate, Microcrystalline Wax/Cire Microcristalline, Nylon-12, Cetyl Ricinoleate, Hydrogenated Coco-Glycerides, Silica, Tribehenin, Punica Granatum Sterols, Polymethyl Methacrylate, Ethylene/Methacrylate Copolymer, Propylparaben, VP/Hexadecene Copolymer, Dimethicone, Ethylparaben, Triethoxycaprylylsilane, Glyceryl Rosinate, Octyldodecyl Myristate, Magnesium Myristate, Butylparaben, Tocopheryl Acetate, Isopropyl Titanium Triisostearate. May Contain: Titanium Dioxide/CI 77891, Iron Oxides, Mica/CI 77019, Bismuth Oxychloride/CI 77163.

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  • QUESTIONS

    Questions or Comments? Call toll free 1-800-FOR-AVON or 1-800-265-AVON in Canada

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  • INGREDIENTS AND APPEARANCE
    EXTRALASTING  CREAM-TO-POWDER FOUNDATION
    octinoxate, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10096-0231
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 63.4 mg  in 1 g
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 30 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10096-0231-2 1 in 1 CARTON
    1 NDC:10096-0231-1 9 g in 1 CASE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 12/15/2010
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    Name Address ID/FEI Business Operations
    Avon Products, Inc. 544863277 manufacture(10096-0231)
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