Label: CLEARSKIN PROFESSIONAL OIL FREE- octinoxate, octisalate, oxybenzone, avobenzone 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 February 11, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient
    OCTINOXATE 7.11%, OCTISALATE 4.5%,
    OXYBENZONE 3.0%, AVOBENZONE 2.5%.......

    Purpose

    .....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 at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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,PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, THIODIPROPIONIC ACID, RETINYL PALMITATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES/ZINC FERMENT, GLYCOLIC ACID, SALICYLIC ACID, PYRIDOXINE HCL,TOCOPHEROL, PALMITOYL OLIGOPEPTIDE,PALMITOYL TETRAPEPTIDE- 7, GLYCERIN, ALUMINUM STARCH OCTENYLSUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SILICA, ISOHEXADECANE, ACRYLATES CROSSPOLYMER, PEG-100 STEARATE, CAPRYLYL GLYCOL, HYDROGENATED POLYISOBUTENE, HYDROXYETHYLCELLULOSE, XANTHAN GUM, CHOLETH-24, POLYSORBATE 60, CETETH-24, ISODODECANE, SORBITAN ISOSTEARATE, POLYSTYRENE/HYDROGENATED POLYISOPENTENE COPOLYMER, BUTYLENE GLYCOL, CARBOMER, POLYSORBATE 20, STEARETH-2, AMMONIUM HYDROXIDE, CETYL ALCOHOL, STEARIC ACID, DISODIUM EDTA, PHENOXYETHANOL, PARFUM/FRAGRANCE.

  • QUESTIONS

    Questions or comments?

    Call toll free 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    CLEARSKIN PROFESSIONAL  OIL FREE
    octinoxate, octisalate, oxybenzone, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 71.1 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0185-21 in 1 CARTON
    1NDC:10096-0185-175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/21/2009
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture(10096-0185)