LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ANTHELIOS 60 MELT-IN SUNSCREEN MILK SPF 60 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]

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  • LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ANTHELIOS 60 MELT-IN SUNSCREEN MILK SPF 60 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]

LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ANTHELIOS 60 MELT-IN SUNSCREEN MILK SPF 60 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-032-01
Set ID d7e8965d-aa36-49db-966f-623869a0b26b
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 5%

    Oxybenzone 6%

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 40 minutes of activity in the water or perspiring
    • provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin
  • Directions

    • apply evenly before sun exposure
    • reapply as needed or after towel drying, swimming, or perspiring
    • children under 6 months of age: ask a doctor
  • Warnings

    For external use only

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    rash or irritation develops and lasts

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Inactive ingredients

    WATER
    STYRENE/ACRYLATES COPOLYMER
    SILICA
    BUTYLOCTYL SALICYLATE
    CYCLOPENTASILOXANE
    GLYCERIN
    ALCOHOL DENAT.
    POLY C10-30 ALKYL ACRYLATE
    DIETHYLHEXYL SYRINGYLIDENEMALONATE
    POLYMETHYLSILSESQUIOXANE
    CAPRYLYL METHICONE
    TRISILOXANE
    ACRYLATES/DIMETHICONE COPOLYMER
    PEG-100 STEARATE
    GLYCERYL STEARATE
    PHENOXYETHANOL
    POTASSIUM CETYL PHOSPHATE
    DIMETHICONE
    TOCOPHERYL ACETATE
    CAPRYLYL GLYCOL
    METHYLPARABEN
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
    CHLORPHENESIN
    INULIN LAURYL CARBAMATE
    TRIETHANOLAMINE
    ETHYLPARABEN
    XANTHAN GUM
    ETHYLHEXYLGLYCERIN
    DISODIUM EDTA
    CASSIA ALATA LEAF EXTRACT
    MALTODEXTRIN

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK SPF 60 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-032
    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) Octocrylene50 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-032-011 in 1 CARTON08/01/200912/04/2013
    1150 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 finalpart35208/01/2009
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products Inc185931458manufacture(49967-032)
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