Label: GARNIER OMBRELLE ULTRA LIGHT ADVANCED 60 FACE SUNSCREEN- drometrizole trisiloxane, octocrylene, bemotrizinol, octisalate, avobenzone, homosalate and ensulizole lotion

  • NDC Code(s): 49967-046-01
  • 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

    DROMETRIZOLE TRISILOXANE 7%
    OCTOCRYLENE 5%
    BEMOTRIZINOL 5%
    OCTISALATE 5%
    AVOBENZONE 3%
    HOMOSALATE 2%
    ENSULIZOLE 0.50%

  • Warnings

    For external use only. Do not use on broken skin. When using this product avoid contact witheyes. If contact occurs, rinse thoroughlly 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 adolescents 12 to 17 years.
    Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk: regularly use a Broad Spectrum SPF 15 or higher sunscreen. Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses.

  • Inactive ingredients

    wwater, alcohol denat., silica, isopropyl myristate, glycerin, diisopropyl sebacate, propanediol, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, perlite, tocopherol, triethanolamine, caprylyl glycol, hydroxyethylcellulose, acrylates/c10-30 alkyl acrylate crosspolymer, pentylene glycol, butylene glycol, citric acid

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE ULTRA LIGHT ADVANCED 60 FACE SUNSCREEN 
    drometrizole trisiloxane, octocrylene, bemotrizinol, octisalate, avobenzone, homosalate and ensulizole lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE70 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL50 mg  in 1 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PERLITE (UNII: 0SG101ZGK9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-046-011 in 1 CARTON01/01/2023
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only01/01/2023
    Labeler - L'OREAL USA PRODUCTS INC (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(49967-046) , pack(49967-046)
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