Label: SOLUTIONS A.M. TOTAL RADIANCE- octinoxate, octisalate and avobenzone lotion

  • NDC Code(s): 10096-0168-1, 10096-0168-2, 10096-0168-3
  • 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
    Octinoxate 7.5%.......................................
    Octisalate 5.0%........................................
    Avobenzone 2.0%....................................

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

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  • DOSAGE & ADMINISTRATION

    Uses
    • helps prevent sunburn

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  • WARNINGS

    Warnings
    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    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 generously and evenly 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

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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, Butylene Glycol, Glycerin, Cyclopentasiloxane, Hydrogenated Polyisobutene, Hydroxyethyl Urea, Dimethicone, Lauryl Lactate, Dilauryl Thiodipropionate, Calcium PCA, Lactoferrin, Palmitoyl Oligopeptide, Saccharomyces Ferment Filtrate, Saccharomyces Lysate Extract, Phospholipids, Phytol, Tocopheryl Acetate, Aframomum Melegueta Seed Extract, Butyrospermum Parkii (Shea Butter), Ceramide 2, Cholesterol, DNA, Foeniculum Vulgare (Fennel) Seed Extract, Viola Tricolor Extract, Yeast Extract, PEG-10 Rapeseed Sterol, Urea, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, PEG-100 Stearate, Pentylene Glycol, Hexylene Glycol, Caprylyl Glycol, Boron Nitride, Silica, Isohexadecane, Cetyl Alcohol, Dimethiconol, Tribehenin, Polysorbate 60, Sorbitan Isostearate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene/Ethylene/Styrene Copolymer, Ethylene/Propylene/Styrene Copolymer, Dimethicone Crosspolymer, Fragrance, Carbomer, Sodium Dehydroacetate, Chlorphenesin, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

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  • QUESTIONS

    Questions or comments?
    Call toll free 1-800-FOR-AVON

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  • INGREDIENTS AND APPEARANCE
    SOLUTIONS  A.M. TOTAL RADIANCE
    octinoxate, octisalate, avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10096-0168
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 mL
    OCTISALATE (OCTISALATE) OCTISALATE 50 mg  in 1 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10096-0168-2 1 in 1 CARTON
    1 NDC:10096-0168-1 118 mL in 1 BOTTLE, PUMP
    2 NDC:10096-0168-3 1.1 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 02/08/2013
    Labeler - Avon Products, Inc (001468693)
    Establishment
    Name Address ID/FEI Business Operations
    Avon Products, Inc 005149471 manufacture(10096-0168)
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