Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 45 ULTRA LIGHT SUNSCREEN FLUID BROAD SPECTRUM SPF 45 SUNSCREEN WATER RESISTANT 40 MINUTES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

  • NDC Code(s): 49967-039-01
  • Packager: L'Oreal USA Products Inc
  • 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 November 14, 2016

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

  • Active ingredient

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

    Oxybenzone 6%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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.

  • Directions

    For sunscreen use: 

    ●  shake well before use

    ●  apply generously 15 minutes before sun exposure

    ●  reapply:

        ●  after 40 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

    ●  children under 6 months of age: Ask a doctor

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    water, alcohol denat., cyclopentasiloxane, silica, styrene/acrylates copolymer, dicaprylyl ether, PEG-30 dipolyhydroxystearate, cyclohexasiloxane, polymethylsilsesquioxane, isononyl isononanoate, nylon-12, dicaprylyl carbonate, lauryl PEG/PPG-18/18 methicone, phenoxyethanol, caprylyl glycol, poly C10-30 alkyl acrylate, methylparaben, sodium chloride, tocopherol, disteardimonium hectorite, dodecene, disodium EDTA, poloxamer 407, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

  • Questions or comments?

    1-888-LRP-LABO 1-888-577-5226

    Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 45 ULTRA LIGHT SUNSCREEN FLUID BROAD SPECTRUM SPF 45 SUNSCREEN WATER RESISTANT 40 MINUTES 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-039-011 in 1 CARTON01/01/2014
    1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-039)