AVON ELEMENTS SKIN REVITALIZE INSTANT RADIANCE (OCTINOXATE, OXYBENZONE, HOMOSALATE, AVOBENZONE) LOTION [NEW AVON LLC]

AVON ELEMENTS SKIN REVITALIZE INSTANT RADIANCE (OCTINOXATE, OXYBENZONE, HOMOSALATE, AVOBENZONE) LOTION [NEW AVON LLC]
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NDC 10096-0302-1, 10096-0302-2, 10096-0302-3
Set ID 3b51c0a2-dfce-45cd-8ef3-585ec86ab618
Category HUMAN OTC DRUG LABEL
Packager New Avon LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients
    Octinoxate 7.5%.................................
    Oxybenzone 3.5%..............................
    Homosalate 3.0%...............................
    Avobenzone 2.5%...............................

    Purpose
    ............... 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 month 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, propanediol, glycerin, DI-C12-15 alkyl fumarate, dilauryl thiodipropionate, PEG-8, steareth-2, silica, ethylhexyl isononanoate, steareth-21, aronia melanocarpa fruit juice, zizyphus jujuba fruit extract, petasites hybridus leaf extract, saccharomyces/platinum ferment, stearyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, silica dimethyl silylate, polyester-1, PEG-200, polyurethane-40, carbomer, tromethamine, disodium EDTA, 1,2-hexanediol, caprylyl glycol, parfum/fragrance, iron oxides, mica/CI 77019, titanium dioxide/CI 77891.

  • QUESTIONS

    Questions or comments?
    Call toll free 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of labelimage of label

  • INGREDIENTS AND APPEARANCE
    AVON ELEMENTS  SKIN REVITALIZE INSTANT RADIANCE
    octinoxate, oxybenzone, homosalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE35 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE30 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0302-21 in 1 CARTON
    1NDC:10096-0302-150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10096-0302-31.1 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2013
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc005149471manufacture(10096-0302)

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