Label: GARNIER OMBRELLE SPF 60 COMPLETE LIGHTWEIGHT- homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion

  • NDC Code(s): 49967-081-01, 49967-081-02, 49967-081-03, 49967-081-04, view more
    49967-081-05
  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Homosalate 10%

    Octocrylene 7%

    Octisalate 5%

    Avobenzone 4%

    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

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPF 60 COMPLETE LIGHTWEIGHT 
    homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-081
    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) OCTOCRYLENE70 mg  in 1 mL
    octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) octisalate50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE40 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:49967-081-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    2NDC:49967-081-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    3NDC:49967-081-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    4NDC:49967-081-04200 mL in 1 PACKAGE; Type 0: Not a Combination Product12/16/2014
    5NDC:49967-081-0590 mL in 1 TUBE; Type 0: Not a Combination Product12/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only12/16/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, INC.624244349manufacture(49967-081)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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