Label: ANEW SOLAR ADVANCE SUNSCREEN BODY MIST- homosalate, octinoxate, octisalate, oxybenzone, avobenzone, octocrylene spray

  • 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 April 11, 2011

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  • DOSAGE & ADMINISTRATION

    To Use: Apply liberally and evenly 15 minutes before sun
    exposure. Spray evenly over skin and rub in. Reapply as
    needed or after towel drying, swimming, or perspiring. Children
    under 6 months of age: ask a doctor.

  • WARNINGS

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

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. Higher SPF gives more
    sunscreen protection. Moderate sun protection product.
    Retains SPF after 80 minutes of activity in the water.

  • SAFE HANDLING WARNING

    Flammable, contents under pressure. Keep away from flame,
    fire or extreme heat. Do not place in hot water or near
    radiators, stove, or other sources of heat. Do not use in
    presence of open flame or sparks. Do not store at
    temperatures above 120°F.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS/ INGREDIENTES ACTIVOS:
    HOMOSALATE 8.00%, OCTINOXATE 7.5%, OCTISALATE
    4.75%, OXYBENZONE 4.75%, AVOBENZONE 2.85%,
    OCTOCRYLENE 2.56%.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS/OTROS INGREDIENTES: SD
    ALCOHOL 40-B, C12-15 ALKYL BENZOATE, PPG-2
    MYRISTYL ETHER PROPIONATE, DIMETHICONE, GLYCERIN,
    ACRYLATES/OCTYLACRYLAMIDE COPOLYMER,
    POLYESTER-8, 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,
    CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL,
    PARFUM/ FRAGRANCE, WATER/EAU.

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    ANEW SOLAR ADVANCE  SUNSCREEN BODY MIST
    homosalate, octinoxate, octisalate, oxybenzone, avobenzone, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 12 mL  in 150 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 11.25 mL  in 150 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 7.125 mL  in 150 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 7.125 mL  in 150 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 4.275 mL  in 150 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3.84 mL  in 150 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0254-21 in 1 CARTON
    1NDC:10096-0254-1150 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/11/2011
    Labeler - Avon Products, Inc. (001468693)
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