Label: AVON ELEMENTS YOUTH RESTORING MULTI-PURPOSE- homosalate, octinoxate, oxybenzone, avobenzone lotion

  • 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
    Homosalate 8.0%............................
    Octinoxate 5.0%..............................
    Oxybenzone 4.0%...........................
    Avobenzone 2.9%...........................

    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

    ​For sunscreen use:

    • 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. May stain certain types of fabrics.
  • INACTIVE INGREDIENT

    Inactive ingredients:
    water/eau, butylene glycol, glycerin, dimethicone, PEG-8, trisiloxane, ethylhexyl isononanoate, HDI/trimethylol hexyllactone crosspolymer, cetyl alcohol, caprylyl glycol, behenyl alcohol, carbomer, dilauryl thiodipropionate, galactoarabinan, parfum/fragrance, phytol, thiodipropionic
    acid, sodium hydroxide, glyceryl stearate, phenoxyethanol, trimethylsiloxysilicate, hydrogenated lecithin, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, polyglyceryl-3 diisostearate, choleth-24, hexylene glycol, tocopherol, ceteth-24, panthenol, silica, tocopheryl
    acetate, sesbania grandiflora flower extract, amethyst extract, phospholipids, pueraria lobata symbiosome extract, saccharomyces/calcium ferment, zea mays (corn) kernel extract, sphingolipids, saccharomyces/copper ferment, saccharomyces/potassium ferment, saccharomyces/magnesium ferment, saccharomyces/zinc ferment, saccharomyces/manganese ferment, saccharomyces/iron ferment, saccharomyces/silicon ferment.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    AVON ELEMENTS  YOUTH RESTORING MULTI-PURPOSE
    homosalate, octinoxate, oxybenzone, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0318-21 in 1 CARTON
    1NDC:10096-0318-150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:10096-0318-31.1 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 finalpart35203/17/2014
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc005149471manufacture(10096-0318)