Label: ANEW REJUVENATE 24 HOUR EYE MOISTURIZER- octinoxate, octisalate, avobenzone, homosalate cream

  • 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 7.50%, OCTISALATE 5.0%,
    AVOBENZONE 2.0%, HOMOSALATE 2.0%..............................

    Purpose
    ................................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 had 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 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
  • STORAGE AND HANDLING

    Other Information
    protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients:WATER/EAU, GLYCERIN, DIMETHICONE, BUTYLENE GLYCOL, PEG-8, POTASSIUM CETYL PHOSPHATE, PHENYL TRIMETHICONE, CETEARYL ALCOHOL, ISODECYL ISONONANOATE, PHYTOL, POLYMETHYL METHACRYLATE, TINOSPORA CORDIFOLIA ROOT/STEM EXTRACT, PINUS TAEDA BARK EXTRACT, RETINOL/SACCHAROMYCES POLYPEPTIDE, PHAEODACTYLUM TRICORNUTUM EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, PLANKTON EXTRACT, HYDROLYZED MILK
    PROTEIN, SODIUM HYALURONATE, ANDROGRAPHOLIDE, PANTHENOL, TOCOPHEROL, KAEMPFERIA GALANGA ROOT EXTRACT, ORYZANOL, CETEARYL GLUCOSIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, CARBOMER, TROMETHAMINE, SODIUM DEHYDROACETATE, CHLORPHENESIN, PHENOXYETHANOL, DISODIUM EDTA.

  • QUESTIONS

    Questions?1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of carton

  • INGREDIENTS AND APPEARANCE
    ANEW REJUVENATE  24 HOUR EYE MOISTURIZER
    octinoxate, octisalate, avobenzone, homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0149
    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
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0149-21 in 1 CARTON
    1NDC:10096-0149-110 mL in 1 JAR
    2NDC:10096-0149-31.1 mL in 1 PACKET
    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(10096-0149)
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