AVON SUN SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NEW AVON LLC]

AVON SUN SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NEW AVON LLC]
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NDC 10096-0295-1
Set ID 05b5dc15-f13c-4667-bb17-74af77d6f9be
Category HUMAN OTC DRUG LABEL
Packager New Avon LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients
    HOMOSALATE 8.00%..................

    OXYBENZONE 4.75%.....................

    OCTISALATE 4.75%.....................

    AVOBENZONE 2.80%...................

    OCTOCRYLENE 2.50%..................

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

    .................................Sunscreen

    .................................Sunscreen

    .................................Sunscreen

    .................................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 after 80 minutes of swimming or sweating
      • immediately after towel drying

      • at least every 2 hours

    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, BUTYLOCTYL SALICYLATE, BUTYLENE GLYCOL, GLYCERIN, PEG-8, POLYESTER-7, NEOPENTYL GLYCOL DIHEPTANOATE, VP/EICOSENE COPOLYMER, DIMETHICONE, CAPRYLYL GLYCOL, CETYL ALCOHOL, TROMETHAMINE, GLYCERYL STEARATE, TRIMETHYLSILOXYSILICATE, HYDROGENATED LECITHIN, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA,
    POLYGLYCERYL-3 DIISOSTEARATE, 1,2-HEXANEDIOL, METHYLBENZYL ALCOHOL, PARFUM/FRAGRANCE, ALOE BARBADENSIS LEAF EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, PHYTOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT,

  • QUESTIONS

    Questions?
    Call toll free1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of label

  • INGREDIENTS AND APPEARANCE
    AVON SUN  SUNSCREEN
    homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE47.5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0295-1236 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 finalpart35203/26/2013
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc005149471manufacture(10096-0295)

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