LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 FACE ULTRA LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 60 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 FACE ULTRA LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 60 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL
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NDC 49967-129-01, 49967-129-02
Set ID 329b48ce-f3cd-44e8-8446-7e51057efb2e
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Homosalate 10.72 %

    Octisalate 3.21%

    Octocrylene 6%

    Oxybenzone 3.86%

  • 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

    ● apply to all skin exposed to the sun [this statement is optional]

    ● reapply:

    ● after 80 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, diethylhexyl syringlyidenemalonate, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl  PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, caprylic/capric triglyceride, poly C10-30 alkyl acrylate, disteardimonium hectorite, isostearyl alcohol, p-anisic acid, disodium EDTA, 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 60 FACE ULTRA LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 60 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-129
    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) HOMOSALATE107.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32.1 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE38.6 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)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    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)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DODECENE (UNII: WYE669F3GR)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-129-011 in 1 CARTON06/01/2013
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-129-021 in 1 CARTON06/01/2013
    23 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2013
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-129) , analysis(49967-129)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interspray364829903pack(49967-129)

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