Label: AVON ELEMENTS YOUTH-RESTORING ANTI-WRINKLE MOISTURE- octinoxate, octisalate, oxybenzone, avobenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 19, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredients
    Octinoxate 7.12%....................................
    Octisalate 4.75%.....................................
    Oxybenzone 2.00%.................................
    Avobenzone 2.00%.................................

    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, butylene glycol, cetearyl alcohol, isononyl isononanoate, dimethicone, silica, dilauryl thiodipropionate, saccharomyces/calcium
    ferment, amethyst extract, glycine soja (soybean) seed extract, daucus carota sativa (carrot) root extract, saccharomyces/copper ferment,
    saccharomyces ferment lysate filtrate, saccharomyces/magnesium ferment, saccharomyces/potassium ferment, saccharomyces/zinc
    ferment, saccharomyces/manganese ferment, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, saccharomyces/iron ferment, saccharomyces/​silicon ferment, kaempferia galanga root extract, parfum/fragrance, polymethylsilsesquioxane, trisiloxane, cetearyl glucoside, phenoxyethanol, choleth-24, glycerin, ceteth-24, ceteareth-20, caprylyl glycol, xanthan gum, carbomer, disodium EDTA, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, 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  YOUTH-RESTORING ANTI-WRINKLE MOISTURE
    octinoxate, octisalate, oxybenzone, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0299
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE71.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0299-21 in 1 CARTON
    1NDC:10096-0299-150 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:10096-0299-31.1 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(10096-0299)