Label: GARNIER OMBRELLE SPF 30 COMPLETE LIGHTWEIGHT- homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion

  • NDC Code(s): 49967-012-01, 49967-012-02, 49967-012-03, 49967-012-04
  • 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 10%

    Octocrylene 5.5%

    Octisalate 5%

    Avobenzone 3%

    Drometrizole Trisiloxane 2.5%

    Terephthalylidene Dicamphor Sulfonic Acid 0.5%

  • 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 out of eyes. 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. Use a water resistant sunscreen if swimming or sweating. For use on children less than 6 months of age, consult a health care practitioner.

  • Others

    Aqua, Glycerin, Alcohol Denat., Styrene/Acrylates Copolymer, Dimethicone, Propylene Glycol, PEG-100 Stearate, Glyceryl Stearate, Silica, Synthetic Wax, Phenoxyethanol, Sodium Polyacrylate, Triethanolamine, Stearic Acid, Caprylyl Glycol, Palmitic Acid, PEG-8 Laurate, Xanthan Gum, Tocopherol, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

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    image of a label
  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPF 30 COMPLETE LIGHTWEIGHT 
    homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE55 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) (AVOBENZONE - UNII:G63QQF2NOX) DROMETRIZOLE TRISILOXANE25 mg  in 1 mL
    ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-012-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2013
    2NDC:49967-012-02240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2013
    3NDC:49967-012-03200 mL in 1 PACKAGE; Type 0: Not a Combination Product09/25/2013
    4NDC:49967-012-0490 mL in 1 TUBE; Type 0: Not a Combination Product09/25/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only09/25/2013
    Labeler - L'OREAL USA PRODUCTS INC (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC624244349manufacture(49967-012)
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