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

  • Category: HUMAN OTC DRUG LABEL

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 February 17, 2016

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  • ACTIVE INGREDIENT

    Active ingredients

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

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

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

  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn

  • 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.

  • 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

  • STORAGE AND HANDLING

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

  • 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.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFBimage of DFB

  • INGREDIENTS AND APPEARANCE
    EXTRALASTING  CREAM-TO-POWDER FOUNDATION
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE63.4 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0231-21 in 1 CARTON
    1NDC:10096-0231-19 g in 1 CASE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/15/2010
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.544863277manufacture(10096-0231)
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