Label: ANEW MEN DAILY MOISTURIZER- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone 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 March 1, 2016

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

  • ACTIVE INGREDIENT

    Active ingredients
    Avobenzone 2.8%...........................
    Homosalate 9.5%...........................
    Octinoxate 7.5%............................
    Octocrylene 2.56%.......................
    Oxybenzone 4.75%........................

    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

    ​For sunscreen use:
    • apply liberally 15 minutes before sun exposure
    • children under 6 months 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

  • INACTIVE INGREDIENT

    Inactive ingredients
    water/eau, propanediol, butyloctyl salicylate, dimethicone, dilauryl thiodipropionate, polymethylsilsesquioxane, silica, ceteareth-20,cocos nucifera (coconut) seed butter, glycerin, PEG-8, polysilicone-11, phenoxyethanol, stearoxytrimethylsilane, cetearyl alcohol, ceteth-2, hydrogenated lecithin, stearyl alcohol, caprylyl glycol, hydrolyzed wheat protein, hydroxyethyl acrylate/sodium acryloyldimethyl taurate
    copolymer, isohexadecane, tromethamine, carbomer, disodium edta, oryzanol, phyllanthus emblica fruit extract, phytol, hydrolyzed wheat
    starch, polysorbate 60, laureth-12, camellia sinensis leaf extract, caprylic/capric triglyceride, cinnamido benzylpiperidinyl ethoxypropylbenzamide, retinol/saccharomyces polypeptide, phaeodactylum tricornutum extract, tocopherol.

  • QUESTIONS

    Questions?
    1-800-FOR-AVON or 1-800-265-AVON in Canada

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFBimage of DFBimage of DFB

  • INGREDIENTS AND APPEARANCE
    ANEW MEN  DAILY MOISTURIZER
    avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE95 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25.6 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE47.5 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0326-21 in 1 CARTON
    1NDC:10096-0326-130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:10096-0326-41 in 1 CARTON
    2NDC:10096-0326-37 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10096-0326-51.1 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/20/2015
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc005149471manufacture(10096-0326)