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

  • NDC Code(s): 49967-222-01
  • 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 December 7, 2017

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

  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

    Ocybenzone 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:

    ● 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, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexsiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, methylparaben, poly c10-30 alkyl acrylate, disteardimonium hectorite, disodium EDTA, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, dodecene, poloxamer 407

  • 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 WATER RESISTANT 40 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-222
    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
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ALCOHOL (UNII: 3K9958V90M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    NYLON-12 (UNII: 446U8J075B)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DODECANE (UNII: 11A386X1QH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-222-011 in 1 CARTON04/01/2010
    150 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 finalpart35204/01/2010
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-222) , analysis(49967-222)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM COSMETIQUE SAS275359578pack(49967-222)