Label: GARNIER OMBRELLE SPF 60 FACE ULTRA LIGHT- octocrylene, titanium dioxide, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion

  • NDC Code(s): 49967-813-01, 49967-813-02, 49967-813-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated May 11, 2022

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  • Active ingredients

    Octocrylene 10%

    Titanium Dioxide 4.15%

    Avobenzone 3.5%

    Drometrizole Trisiloxane 3%

    Terephthalylidene Dicamphor Sulfonic Acid 3%

  • Caution

    For external use only. Discontinue use if skin irratation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Before use on children under 6 months, consult a doctor. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

  • Directions

    Apply generously 15 to 30 minutes before sun exposure. Reapply at least every 2 hours or after swimming, washing, towel drying or perspiring heavily.

  • Others

    Aqua, Propylene Glycol, Glycerin, Cyclopentasiloxane, Triethanolamine, Isopropyl Palmitate, Stearic Acid, VP/Eicosene Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Hydroxide, Carbomer, Disodium EDTA, Glyceryl Stearate, Glycine Soja, Hydroxypropyl Methylcellulose, Methylparaben, PEG-100 Stearate, Phenoxyethanol, Propylparaben, Stearyl alcohol, Tocopherol

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPF 60 FACE ULTRA LIGHT 
    octocrylene, titanium dioxide, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE41.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE35 mg  in 1 mL
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE30 mg  in 1 mL
    ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-813-0175 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2011
    2NDC:49967-813-026 mL in 1 TUBE; Type 0: Not a Combination Product10/30/2013
    3NDC:49967-813-0390 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only10/10/2011
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC624244349manufacture(49967-813)
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