Label: AVON CARE MOISTURE REPLENISH DAILY HYDRATING- octinoxate, oxybenzone 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 12, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients
    Octinoxate 7.5%...................
    Oxybenzone 3.5%................

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

  • INDICATIONS & USAGE

    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/EAU, C12-15 ALKYL BENZOATE, GLYCERIN, GLYCERYL STEARATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, RETINYL PALMITATE, ASCORBYL PALMITATE, TOCOPHERYL ACETATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TOCOPHEROL, CETYL LACTATE, PEG-40 STEARATE, HYDROGENATED POLYISOBUTENE, STEARETH-2, CARBOMER, XANTHAN GUM, PARFUM/FRAGRANCE, POTASSIUM HYDROXIDE, DISODIUM EDTA, TETRASODIUM EDTA, PHOSPHORIC ACID, IMIDAZOLIDINYL UREA, METHYLPARABEN.

  • 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 labelimage of labelimage of label

  • INGREDIENTS AND APPEARANCE
    AVON CARE  MOISTURE REPLENISH DAILY HYDRATING
    octinoxate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0262
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE35 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0262-1200 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/13/2011
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture(10096-0262)