Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

  • NDC Code(s): 49967-095-01, 49967-095-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

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

  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

    Oxybenzone 6%

  • Uses

    • helps prevent sunburn
    • if used as directed (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 at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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 of 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

  • Purpose

    Sunscreen

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    dimethicone, C12-15 alkyl benzoate, talc, diisopropyl sebacate, silica, silica silylate, glycerin, trimethylsiloxysilicate, dimethicone crosspolymer, water, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

  • Questions or comments?

    1-888-LRP-LABO  1-888-577-5226

    Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-095
    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
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    WATER (UNII: 059QF0KO0R)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-095-011 in 1 CARTON04/05/2012
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-095-021 in 1 CARTON04/05/2012
    240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/05/2012
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products Inc185931458analysis(49967-095)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(49967-095) , pack(49967-095)