AVON SUN SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) AEROSOL, SPRAY [NEW AVON LLC]

AVON SUN SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) AEROSOL, SPRAY [NEW AVON LLC]
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NDC 10096-0296-1
Set ID 9d7238bb-8237-4cc8-8c4d-8d815a22a166
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%..................

    OCTINOXATE 7.5%.....................

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

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

    AVOBENZONE 2.85%...................

    OCTOCRYLENE 2.56%..................

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

    .................................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.
    • keep away from face to avoid breathing it.

    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.

    ​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 temparatures above 120F (50C). Do not tamper with valve closure or puncture or incinerate can.

  • DOSAGE & ADMINISTRATION

    Directions
    • spray generously and spread evenly by hand 15 minutes before sun exposure

    • hold container 4 to 6 inches from skin to apply

    • do not spray directly into face

    • Spray on hands, then apply to face

    • do not apply in windy conditions

    • use in well-ventilated areas
    • 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:
    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

  • QUESTIONS

    Questions?
    Call toll free1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    AVON SUN  SUNSCREEN
    homosalate, octinoxate, octisalate, oxybenzone, avobenzone, octocrylene aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0296
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE47.5 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25.6 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0296-1136.5 g in 1 BOTTLE, SPRAY; 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
    Accra Pac, Inc.024213616manufacture(10096-0296)

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