Label: ANEW SOLAR ADVANCE EYE AND LIP SUNSCREEN- titanium dioxide, zinc oxide 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 December 21, 2010

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  • DOSAGE & ADMINISTRATION

    Eye Cream Sunscreen To Use: Apply
    evenly and smooth over upper eyelid,
    under eye area, and along crow’s feet
    before sun exposure and as needed.
    Children under 6 months of age: ask a
    doctor.


    Warning: When using this
    product, keep out of eyes. Rinse with
    water to remove. Stop use and ask a
    doctor if rash or irritation develops and
    lasts. For external use only. Keep out of
    reach of children.

  • DOSAGE & ADMINISTRATION

    Glossy Lip Tint Sunscreen To Use:
    Smooth evenly over lips before sun
    exposure with fingertip.

    Warning: Stop
    use if rash occurs. Keep out of reach of
    children.

  • INDICATIONS & USAGE

    Uses for both: Helps prevent
    sunburn. Higher SPF gives more
    sunburn protection.

  • ACTIVE INGREDIENT

    EYE CREAM ACTIVE
    INGREDIENTS/INGREDIENTES
    ACTIVOS DE LA
    CREMA PARA LOS OJOS:
    TITANIUM DIOXIDE 3.1%,
    ZINC OXIDE 6.9%.

    OTHER INGREDIENTS/
    OTROS INGREDIENTES:
    WATER/EAU, DIMETHICONE,
    GLYCERIN, SIMMONDSIA
    CHINENSIS (JOJOBA) SEED
    OIL, DIMETHICONE CROSSPOLYMER,
    PROPYLENE
    GLYCOL, ISOCETYL STEAROYL
    STEARATE, ISODECYL
    ISONONANOATE, PHENYL
    TRIMETHICONE, MAGNESIUM
    SULFATE, VP/HEXADECENE
    COPOLYMER, PEG-10
    DIMETHICONE, LAURYL
    PEG-9 POLYDIMETHYLSILOXYETHYL
    DIMETHICONE,
    THIODIPROPIONIC ACID, GLYCINE
    SOJA (SOYBEAN) SEED
    EXTRACT, PHAEODACTYLUM
    TRICORNUTUM EXTRACT,
    ORYZANOL, FOENICULUM
    VULGARE (FENNEL) FRUIT EXTRACT,
    DAUCUS CAROTA
    SATIVA (CARROT) ROOT EXTRACT,
    GLYCINE MAX (SOYBEAN)
    SYMBIOSOME EXTRACT,
    TOCOPHEROL, TOCOPHERYL
    ACETATE, POLYESTER-
    8, CAPRYLIC/CAPRIC
    TRIGLYCERIDE, SILICA, HYDRATED
    SILICA, POLYMETHYL
    METHACRYLATE, ALUMINUM
    HYDROXIDE, DIMETHICONE/
    METHICONE COPOLYMER,
    DIMETHICONE/DIVINYLDIMETHICONE/
    SILSESQUIOXANE
    CROSSPOLYMER,POLYSORBATE 20, POLYSORBATE
    80, GLYCERYL STEARATE,
    POLYHYDROXYSTEARIC
    ACID, PEG-30 DIPOLYHYDROXYSTEARATE,
    TRIETHOXYCAPRYLYLSILANE,
    ISOHEXADECANE, AMMONIUM
    POLYACRYLOYLDIMETHYL
    TAURATE, AMMONIUM
    HYDROXIDE, CAPRYLYL
    GLYCOL, METHYLPARABEN,
    IMIDAZOLIDINYL UREA,
    DISODIUM EDTA.

  • ACTIVE INGREDIENT

    GLOSSY LIP TINT
    ACTIVE INGREDIENTS/
    INGREDIENTES ACTIVOS
    DEL BRILLO LABIAL: TITANIUM
    DIOXIDE 3.3%,
    ZINC OXIDE 7.2%.

    OTHER INGREDIENTS/
    OTROS INGREDIENTES:
    POLYBUTENE, BIS-DIGLYCERYL
    POLYACYLADIPATE-2,
    C18-36 ACID TRIGLYCERIDE,
    SIMMONDSIA CHINENSIS
    (JOJOBA) SEED OIL, PHENYL
    TRIMETHICONE, ISOCETYL
    STEAROYL STEARATE, ISODECYL
    ISONONANOATE, DIISOSTEARYL
    FUMARATE,
    KAEMPFERIA GALANGA
    ROOT EXTRACT, GLYCINE
    SOJA (SOYBEAN) SEED EXTRACT,
    PHAEODACTYLUM
    TRICORNUTUM EXTRACT,
    ORYZANOL, FOENICULUM
    VULGARE (FENNEL) FRUIT EXTRACT,
    DAUCUS CAROTA
    SATIVA (CARROT) ROOT EXTRACT,
    DILAURYL THIODIPROPIONATE,
    TOCOPHEROL,
    GLYCERIN, WATER/EAU,
    POLYESTER-8, POLYHYDROXYSTEARIC
    ACID, GLYCERYL
    STEARATE, HYDRATED
    SILICA, CAPRYLIC/CAPRIC
    TRIGLYCERIDE, DIMETHICONE/
    METHICONE COPOLYMER,
    ALUMINUM HYDROXIDE,
    TRIETHOXYCAPRYLYLSILANE,
    CAPRYLYL GLYCOL,
    PARFUM/FRAGRANCE, IRON
    OXIDES, MICA/CI 77019,
    CARMINE/CI 75470.

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of cartonimage of cartonimage of cartonimage of cartonimage of package

  • INGREDIENTS AND APPEARANCE
    ANEW SOLAR ADVANCE  EYE AND LIP SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.155 g  in 5 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.345 g  in 5 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.165 g  in 5 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.36 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0241-31 in 1 CARTON
    1NDC:10096-0241-15 g in 1 TUBE, WITH APPLICATOR
    2NDC:10096-0241-31 in 1 CARTON
    2NDC:10096-0241-25 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/21/2010
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture
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