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

  • NDC Code(s): 49967-649-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated June 27, 2024

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  • Active ingredient

    Drometrizole trisiloxane 7%

    Bemotrizinol 5%

    Octisalate 5%

    Octocrylene 5%

    Avobenzone 3%

    Homosalate 2%

    Ensulizole 0.5%

  • Purpose 

    Sunscreen

  • 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, call a poison control centre or get medical help 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 siwmming 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-sleeved shirts, pants, hats, and sunglasses. 
  • Inactive ingredients

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

  • Questions?

    1 888-966-2735 

    (9-Ombrel)

  • PRINCIPAL DISPLAY PANEL

    image of cartonimage of carton

  • PRINCIPAL DISPLAY PANEL

    image of labelimage of label

  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 60 SUNSCREEN 
    drometrizole trisiloxane, bemotrizinol, octisalate, octocrylene, avobenzone, homosalate and ensulizole lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-649
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE70 mg  in 1 mL
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL50 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
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 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)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-649-011 in 1 CARTON02/01/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only02/01/2023
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC624244349manufacture(49967-649)
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