Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS SX DAILY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, ecamsule and octocrylene cream

  • NDC Code(s): 49967-017-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 31, 2023

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  • Active ingredients


    Avobenzone 2%

    Ecamsule 2%

    Octocrylene 10%

  • Purpose

    Sunscreen

  • Uses

    - helps prevent sunburn

    - higher SPF gives more sunburn protection

    - helps provide protection from UVA rays (short and long wavelengths)

  • Warnings

    For external use only

  • Do not use on

    - broken skin

    - serious burns

  • 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.

  • 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

  • Inactive ingredients

    carbomer homopolymer Type C, carbomer copolymer Type B, cyclomethicone, dimethicone, edetate disodium, glycerin, hydroxypropyl methylcellulose, isopropyl palmitate, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearic acid, stearoyl macrogolglycerides, stearyl alcohol, trolamine

  • Questions?

    1-800-308-4516

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

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS SX DAILY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, ecamsule and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE20 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-017-011 in 1 CARTON07/29/201411/23/2024
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02150207/29/201411/23/2024
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories, Ltd.832224526manufacture(49967-017)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories, Ltd.832224690analysis(49967-017)
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