Label: LA ROCHE POSAY FACE BODY ANTHELIOS SPF 60 MELT IN MILK FAST ABSORBING, VELVETY FINISH FOR ALL SKIN TYPES WITH CELL-OC SHIELD XL- avobenzone, homosalate, octisalate and octocrylene lotion

  • NDC Code(s): 49967-355-01, 49967-355-02, 49967-355-03, 49967-355-04, view more
    49967-355-05, 49967-355-06
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

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  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    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
  • Warning

    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 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, sytrene/acrylates copolymer, dimethicone, polymethlysilsesquioxane, butylocytyl salicylate, glycerin, alcohol denat., poly C10-30 alkyl acrylate, caprylyl methicone, trisiloxane, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, propylene glycol, caprylyl glycol, PEG-8 laurate, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, inulin lauryl carbamate, disodium EDTA, p-anisic acid, caprylic/capric triglyceride, xanthan gum, cassia alata leaf extract, maltodextrin

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY FACE BODY ANTHELIOS SPF 60 MELT IN MILK FAST ABSORBING, VELVETY FINISH FOR ALL SKIN TYPES WITH CELL-OC SHIELD XL 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-355
    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) OCTOCRYLENE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    TRISILANE (UNII: 1T3A75Z4ZL)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-355-011 in 1 CARTON12/15/2018
    190 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-355-022 mL in 1 PACKET; Type 0: Not a Combination Product04/01/2019
    3NDC:49967-355-031 in 1 CARTON12/15/2018
    350 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:49967-355-041 in 1 CARTON04/01/2019
    4150 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:49967-355-0515 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
    6NDC:49967-355-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/15/2018
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC.185931458manufacture(49967-355) , pack(49967-355)
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