Label: GARNIER OMBRELLE CLEAR SPORT 50 PLUS WATER RESISTANT 40 MINUTES- avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray

  • NDC Code(s): 49967-739-01
  • 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 5%

    Drometrizole trisiloxane 2%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 7%

  • Warnings

    For external use only. Flammability Warning. Do not use in presence of open flame or spark. When using this product avoid contact witheyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. Stop use and ask a doctor if rash occurs. Other warnings. Contents under pressure, do not place in hot water or near radiator, stoves or other sources of heat, do not puncture or incinerate container or store at temperatures over 50oC. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. 

  • Directions 

    Adults and children over 6 months of age. Shake well before use. Spray generously and spread evenly by hand 15 minutes before sun exposure. Hold container 10 to 15 cm from the skin to apply, do not spray directly onto face. Spray on hand then apply to face. Do not apply in windy conditions and use in a well ventilated area, avoid inhaling or exposing others to spray. Reapply at least every 2 hours, after 80 minutes of swimming or sweating, right after towel drying. 

  • Others

    alcohol denat., c12-15 alkyl benzoate, ethylenediamine/stearyl dimer dilinoleate copolymer, acrylates/octylacrylamide copolymer, tocopherol

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE CLEAR SPORT 50 PLUS WATER RESISTANT 40 MINUTES 
    avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-739
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE50 mg  in 1 mL
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE20 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-739-01122 mL in 1 CONTAINER; Type 0: Not a Combination Product02/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only02/01/2015
    Labeler - L'OREAL USA PRODUCTS INC (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC624244349manufacture(49967-739) , pack(49967-739)
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