Label: ANEW CLINICAL SKINVINCIBLE MULTI-SHIELD- avobenzone, homosalate, octinoxate, octocrylene and oxybenzone lotion 

  • Label RSS
  • NDC Code(s): 10096-0304-1, 10096-0304-2, 10096-0304-3, 10096-0304-4, view more
    10096-0304-5
  • Packager: Avon Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients
    Avobenzone 2.8%...........................
    Homosalate 9.5%...........................
    Octinoxate 7.5%............................
    Octocrylene 2.56%.......................
    Oxybenzone 4.75%........................

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

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  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by
    the sun

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  • 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.

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  • 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
    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

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  • INACTIVE INGREDIENT

    Inactive ingredients
    water/eau, propanediol, butyloctyl salicylate, dimethicone, dilauryl thiodipropionate, polymethylsilsesquioxane, silica, glycerin, cinnamido benzylpiperidinyl ethoxypropylbenzamide, retinol/saccharomyces polypeptide, phyllanthus emblica fruit extract, cocos nucifera (coconut) seed butter, hydrolyzed wheat starch, hydrolyzed wheat protein, oryzanol, phytol, camellia sinensis leaf extract, phaeodactylum tricornutum extract, tocopherol, ceteareth-20, PEG-8, polysilicone-11, stearoxytrimethylsilane, cetearyl alcohol, ceteth-2, hydrogenated lecithin, stearyl alcohol, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylic/capric triglyceride, isohexadecane, carbomer, polysorbate 60, laureth-12, tromethamine, disodium EDTA, phenoxyethanol, parfum/fragrance.

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  • QUESTIONS

    Questions?
    1-800-FOR-AVON

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  • INGREDIENTS AND APPEARANCE
    ANEW CLINICAL  SKINVINCIBLE MULTI-SHIELD
    avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10096-0304
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 28 mg  in 1 g
    HOMOSALATE (HOMOSALATE) HOMOSALATE 95 mg  in 1 g
    OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 25.6 mg  in 1 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 47.5 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10096-0304-2 1 in 1 CARTON
    1 NDC:10096-0304-1 30 g in 1 BOTTLE, PUMP
    2 NDC:10096-0304-4 1 in 1 CARTON
    2 NDC:10096-0304-3 7 g in 1 TUBE
    3 NDC:10096-0304-5 1.1 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/22/2013
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    Name Address ID/FEI Business Operations
    Avon Products, Inc. 005149471 manufacture(10096-0304)
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