Label: ANEW AGE-TRANSFORMING CONCEALER- titanium dioxide and octinoxate cream

  • NDC Code(s): 10096-0138-1, 10096-0138-2
  • 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 02/13

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

  • ACTIVE INGREDIENT

    Active ingredients
    Titanium Dioxide 6.62%.........................
    Octinoxate 2.50%.................................

    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:Water/Eau, Butylene Glycol, Propylene Glycol Dicaprylate/Dicaprate, Cyclopentasiloxane, Glycolic Acid, Polysorbate 60, Glycol Stearate, PPG-2 Myristyl Ether Propionate, Silica, Sorbitan Stearate, Foeniculum Vulgare (Fennel) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Vitis Vinifera (Grape) Fruit Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Olea Europaea (Olive) Leaf Extract, Medicago Sativa (Alfalfa) Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Punica Granatum Extract,
    Hydrolyzed Hibiscus Esculentus Extract, Portulaca Oleracea Extract, Saxifraga Sarmentosa Extract, Tilia Cordata Wood Extract, Panax Ginseng Root Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Yeast Extract/Extrait De Levure, Padina Pavonica Thallus Extract, Hydrolyzed Wheat Protein, Talc, Nylon-12, PEG-12 Dimethicone, Ammonium Hydroxide, Magnesium Aluminum Silicate, Paraffin, Xanthan Gum, Xymenynic Acid, Mannitol, Polymethyl Methacrylate, Phytol, Alumina, Glycogen, PEG-40 Hydrogenated Castor Oil, Calcium Pantothenate, Biotin, Tetrasodium EDTA, Imidazolidinyl Urea, Propylparaben, Methylparaben, Aluminum Hydroxide. May Contain: Iron Oxides, Mica, Bismuth Oxychloride, Titanium Dioxide.

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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
    ANEW AGE-TRANSFORMING  CONCEALER
    titanium dioxide, octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10096-0138
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 66.2 mg  in 1 g
    OCTINOXATE (OCTINOXATE) OCTINOXATE 25 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10096-0138-2 1 in 1 CARTON
    1 NDC:10096-0138-1 1.7 g in 1 VIAL, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 02/09/2013
    Labeler - Avon Products, Inc (001468693)
    Establishment
    Name Address ID/FEI Business Operations
    Avon Products, Inc 005149471 manufacture(10096-0138)
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