Label: AVON SUN SUNSCREEN FACE- homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

  • 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 March 27, 2013

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  • ACTIVE INGREDIENT

    Active ingredients
    HOMOSALATE 9.5%..................

    OXYBENZONE 6.0%.....................

    OCTISALATE 4.75%.....................

    AVOBENZONE 3.0%...................

    OCTOCRYLENE 2.8%..................

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

    .................................Sunscreen

    .................................Sunscreen

    .................................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 generously and evenly 15 minutes before sun exposure
    • children under 6 months of age: ask a doctor
    • reapply after 80 minutes of swimming or sweating
    • immediately after towel drying

    • at least every 2 hours

    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:
    WATER/EAU, BUTYLOCTYL SALICYLATE, DIMETHICONE, PEG-8, STYRENE/ACRYLATES COPOLYMER, SILICA, POLYESTER-7, OLETH-3 PHOSPHATE, NEOPENTYL GLYCOL DIHEPTANOATE, TRISILOXANE, DILAURYL THIODIPROPIONATE, KAEMPFERIA GALANGA ROOT EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PHAEODACTYLUM TRICORNUTUM EXTRACT, ORYZANOL, FOENICULUM VULGARE (FENNEL) FRUIT EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, TOCOPHEROL, POLYESTER-8, VP/EICOSENE COPOLYMER, HYDROXYETHYL UREA, BORON NITRIDE, HYDROXYETHYL ACRYLATES/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DIMETHICONE CROSSPOLYMER, ISOHEXADECANE, PEG-8 LAURATE, HYDROGENATED LECITHIN, POLYGLYCERYL-3 DIISOSTEARATE, POLYSORBATE 60, UREA, GLYCERIN, CALCIUM CHLORIDE, CARYLIC/CAPRIC TRIGLYCERIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TROMETHAMINE, DISODIUM EDTA, CAPRYLYL GLYCOL, PHENOXYETHANOL, PARFUM/FRAGRANCE

  • QUESTIONS

    Questions?
    Call toll free1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    AVON SUN  SUNSCREEN FACE
    homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0294
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE95 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE28 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0294-188 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/26/2013
    Labeler - Avon Products, Inc (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc005149471manufacture(10096-0294)