Label: GARNIER OMBRELLE FACE ANTI-SHINE SPF 60 MEXORYL TECHNOLOGY- homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion

  • NDC Code(s): 49967-209-01, 49967-209-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated December 31, 2023

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  • Active ingredients

    Homosalate 15%

    Octocrylene 7%

    Octisalate 5%

    Avobenzone 3%

    Drometrizole Trisiloxane 0.5%

  • Inactive ingredients

    aqua, silica, styrene/acrylates copolymer, butyloctyl salicylate, dicaprylyl carbonate, methyl methacrylate copolymer, nylon-12, PEG-100 stearate, glyceryl stearate, perlite, cera alba, ammonium polyacryloyldimethyl taurate, behenyl alcohol, chlorphenesin, disodium EDTA, p-anisic acid, PEG-8 laurate, phenoxyethanol, sodium dodecylbenzenesulfonate, sodium stearoyl glutamate, tocopherol, xanthan gum, zinc PCA

  • Warnings

    For external use only

  • Do not use

    on damaged or broken skin

  • When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • 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

    Adults and children 6 months and up. Apply as needed

  • PRINCIPAL DISPLAY PANEL

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    image of a label
  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE FACE ANTI-SHINE SPF 60 MEXORYL TECHNOLOGY 
    homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    NYLON-12 (UNII: 446U8J075B)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PERLITE (UNII: 0SG101ZGK9)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-209-011 in 1 CARTON02/19/2020
    190 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-209-02200 mL in 1 TUBE; Type 0: Not a Combination Product02/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only02/19/2020
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-209)
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