LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE SPORT ANTHELIOS ACTIVEWEAR BROAD SPECTRUM SPF 60 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE SPORT ANTHELIOS ACTIVEWEAR BROAD SPECTRUM SPF 60 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-431-01, 49967-431-02
Set ID 071bfb80-d980-4e62-9cd6-96149f1ba04a
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 15%

    Octisalate 5%

    Octocrylene 7%

  • 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

    • apply generously 15 minutes before sun exposure
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately fter 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 SOF calue of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially between 10 a.m. and 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, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, menthyl methacrylae crosspolymer, nylon-12, PEG-100, glyceryl stearate, perlite, beeswax, ammonium poolyacrylloyldiimethy taurate, behenyl alcohol, caprylic/capric triglyceride, cassia alata leaf extract, chlorphenesisn, diethylhexyl syringlyidenemalonate, disodium EDTA, maltodextrin, p-anisic acid, PEG-8 laurate, phenoxethanol, propylene glycol, sodium stearoyl glutamate, tocopherol, xanthan gum

  • Questions or comments?

    1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE SPORT ANTHELIOS ACTIVEWEAR BROAD SPECTRUM SPF 60 SUNSCREEN 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-431
    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) HOMOSALATE150 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NYLON-12 (UNII: 446U8J075B)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PERLITE (UNII: 0SG101ZGK9)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-431-01150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2017
    2NDC:49967-431-025 mL in 1 PACKET; Type 0: Not a Combination Product10/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/17/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-431)

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