Label: GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC- oxybenzone, octisalate, titanium dioxide, octocrylene and terephthalylidene dicamphor sulfonic acid lotion

  • NDC Code(s): 49967-493-01, 49967-493-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 17, 2020

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  • Active ingredients

    Oxybenzone 5%

    Octisalate 5%

    Titanium Dioxide 4.2%

    Octocrylene 3.5%

    Terephthalylidene Dicamphor Sulfonic Acid 3%

    Avobenzone 2%

  • 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 ouf 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 Center 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.

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC 
    oxybenzone, octisalate, titanium dioxide, octocrylene and terephthalylidene dicamphor sulfonic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-493
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE35 mg  in 1 mL
    ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE30 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-493-011 in 1 CARTON09/24/2011
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-493-021 in 1 CARTON09/24/2011
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only09/24/2011
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.624244349manufacture(49967-493) , pack(49967-493)