Label: GARNIER OMBRELLE SPORT ENDURANCE 60- avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion

  • NDC Code(s): 49967-488-01
  • Packager: L'OREAL USA PRODUCTS INC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 31, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredients

    Avobenzone 3%

    Drometrizole trisiloxane 0.5%

    Homosalate 10.72%

    Octisalate 3.21%

    Octocrylene 6%

    Oxybenzone 3.86%

  • Warnings

    For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. 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 over 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. 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 sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measure including limit time in the sun 11 a.m - 3 p.m and wear long sleeve shirts, pants, hats and sunglasses.

  • Inactive ingredients

    water, dimethicone, alcohol denat., styrene/acrylates copolymer, acrylates/dimethicone copolymer, tocopherol, sodium polyacrylate, phenoxyethanol, PEG-8 laurate, silica, menthyl lactate, caprylyl glycol, acrylates/c10-30 alkyl acrylate crosspolymer, disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPORT ENDURANCE 60 
    avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-488
    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 TRISILOXANE5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE107.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32.1 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE38.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALCOHOL (UNII: 3K9958V90M)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-488-01231 mL in 1 TUBE; Type 0: Not a Combination Product02/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only02/22/2016
    Labeler - L'OREAL USA PRODUCTS INC (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC624244349manufacture(49967-488) , pack(49967-488)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!