Label: GARNIER OMBRELLE SPF 30 SPORT ENDURANCE WATER RESISTANT- avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion

  • NDC Code(s): 49967-747-01, 49967-747-02
  • 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

    Avobenzone 2.24%

    Drometrizole Trisiloxane 0.5%

    Homosalate 8%

    Octisalate 2.4%

    Octocrylene 4.48%

    Oxybenzone 2.88%

  • Warnings

    For external use only. Do not use on damaged or broken skin. If rash occurs, discontinue use and consult a health care practitioner. Keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying. For use on children less than 6 months of age, consult a health care practitioner.

  • Inactive ingredients

    water, alcohol denat., dimethicone, cyclopentsailoxane, tocopherol, sodium polyacrylate, phenoxyethanol, silica, menthyl lactate, caprylyl glycol, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA

  • PRINCIPAL DISPLAY PANEL

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    image of a label
  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPF 30 SPORT ENDURANCE WATER RESISTANT 
    avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-747
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE22.4 mg  in 1 mL
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE24 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE44.8 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE28.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    METHYL LACTATE, (-)- (UNII: 0379G9C44S)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-747-01231 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    2NDC:49967-747-0250 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only01/01/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC.624244349manufacture(49967-747)
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