Label: GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT- octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid cream

  • NDC Code(s): 49967-162-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 21, 2018

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  • Active ingredients

    Octocrylene 5%

    Drometrizole Trisiloxane 4%

    Avobenzone 3%

    Titanium Dioxide 2.9%

    Terephthalylidene Dicamphor Sulfonic Acid 1%

  • Caution

    For external use only. Discontinue use if skin irratation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Before use on children under 6 months, consult a doctor. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

  • Directions

    Apply generously 15 to 30 minutes before sun exposure. Reapply at least every 2 hours or after swimming, washing, towel drying or perspiring heavily.

  • Others

    Aqua, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Glycerin, Pentylene Glycol, Stearic Acid, Triethanolamine, Potassium Cetyl Phosphate, Propylene Glycol, Panthenol, PEG-100 Stearate, Glyceryl Stearate, Phenoxyethanol, Cetyl Alcohol, Dimethicone, Methylparaben, Aluminum Hydroxide, Capryly Glycol, Ethylparaben, Carbomer, Tocopherol, Xanthan Gum, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    image of tube

  • INGREDIENTS AND APPEARANCE
    GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT 
    octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE40 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE29 mg  in 1 mL
    ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-162-0175 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/10/2011
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC624244349manufacture(49967-162)