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

  • 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 February 8, 2013

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  • ACTIVE INGREDIENT

    Active ingredients
    Octinoxate 7.5%.......................................
    Octisalate 5.0%........................................
    Avobenzone 2.0%....................................

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

  • DOSAGE & ADMINISTRATION

    Uses
    • helps prevent sunburn

  • 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.

  • 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

  • STORAGE AND HANDLING

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

  • 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.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of carton

  • INGREDIENTS AND APPEARANCE
    SOLUTIONS  A.M. TOTAL RADIANCE
    octinoxate, octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0168
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0168-21 in 1 CARTON
    1NDC:10096-0168-1118 mL in 1 BOTTLE, PUMP
    2NDC:10096-0168-31.1 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/08/2013
    Labeler - Avon Products, Inc (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc005149471manufacture(10096-0168)
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