Label: GARNIER OMBRELLE KIDS WET N PROTECT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY- homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotion

  • NDC Code(s): 49967-083-01, 49967-083-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated December 31, 2023

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  • Active ingredients

    Homosalate 10.7%
    Octocrylene 6%
    Oxybenzone 3.9%
    Octisalate 3.2%
    Avobenzone 3%
    Drometrizole Trisiloxane 0.5%

  • Inactive ingredients

    Aqua, Dimethicone, Alcohol Denat., Styrene/Acrylates Copolymer, Acrylates/Dimethicone Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Disodium EDTA, PEG-8 Laurate, Phenoxyethanol, Sodium Dodecylbenzenesulfonate, Sodium Polyacrylate, Tocopherol

  • Use:

    Helps prevent sunburn.

  • Warnings

    For external use only.

  • Do not use

    on 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 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. Can be applied on dry or wet skin.

  • PRINCIPAL DISPLAY PANEL

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    image of a label
  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE KIDS WET N PROTECT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY 
    homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49967-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE107 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE39 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32 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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    caprylyl glycol (UNII: 00YIU5438U)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-083-011 in 1 CARTON02/19/2020
    190 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-083-021 in 1 CARTON02/19/2020
    2200 mL in 1 TUBE; Type 0: Not a Combination Product
    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(49967-083) , pack(49967-083)
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