Label: GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT- titanium dioxide, octisalate, drometrizole trisiloxane, avobenzone, octocrylene and ecamsule lotion

  • NDC Code(s): 49967-469-01, 49967-469-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 17, 2020

If you are a consumer or patient please visit this version.

  • Active ingredients

    Titanium Dioxide 5.85%

    Octisalate 5%

    Drometrizole Trisiloxane 4.5%

    Avobenzone 3%

    Octocrylene 2.5%

    Ecamsule 1.5%

  • Caution

    For external use only. Do not use on damaged or broken skin. If rash occurs,discontinue use and consult a health care practitioner. Keep product out of eyes. If contact occurs, rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

  • Directions

    Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 40 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.

  • Others

    Aqua, C12-15 Alkyl Benzoate, Alcohol Denat., Caprylic/Capric Triglyceride, Isododecane, Propylene Glycol, Dimethicone, Glycerin, PEG-30 Dipolyhydroxystearate, Lauryl PEG/PPG-18/18 Methicone, Synthetic Wax, Ammonium Polyacryloyldimethyl Taurate, Silica, Triethanolamine, Cellulose Gum, Caprylyl Glycol, Dimethicone Crosspolymer, Isostearyl Alcohol, Dedecene, Poloxamer 407, Glycine Soja Oil, Tocopherol, Pentasodium Ethylenediamine Tetramethylene Phosphonate, Hydrolyzed Algin, Magnesium Sulfate, Manganese Sulfate, Benzyl Benzoate, Benzyl Alcohol

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT 
    titanium dioxide, octisalate, drometrizole trisiloxane, avobenzone, octocrylene and ecamsule lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-469
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE58.5 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE45 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
    ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISODODECANE (UNII: A8289P68Y2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DODECENE (UNII: WYE669F3GR)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEXIDRONAM PENTASODIUM (UNII: 2ZYX2V82AD)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-469-01120 in 1 CARTON07/28/2015
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-469-02240 in 1 CARTON07/28/2015
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only07/28/2015
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.624244349manufacture(49967-469) , pack(49967-469)