Label: LOREAL PARIS OMBRELLE SPF 30 COMPLETE WATER RESISTANT- avobenzone, octocrylene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion

  • NDC Code(s): 49967-000-01, 49967-000-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 17, 2020

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

  • Active ingredients

    Avobenzone 3%

    Octocrylene 10%

    Terephthalylidene Dicamphor Sulfonic Acid 1%

    Titanium Dioxide 2.2%

  • Warnings

    For external use only. Discontinue use if irritation 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 (a palmful for an adult body) 15 to 30 minutes before sun exposure. Reapply every 2 hours or as needed after swimming, washing, towel drying or perspiring heavily.

  • Inactive ingredients

    water, propylene glycol, glycerin, cyclopentasiloxane, isopropyl palmitate, stearic acid, triethanolamine, VP/eicosene copolymer, dimethicone, panthenol, phenoxyethanol, PEG-100 stearate, glyceryl stearate, methylparaben, aluminum hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, tocopherol, disodium EDTA, propylparaben, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    LOREAL PARIS OMBRELLE SPF 30 COMPLETE WATER RESISTANT 
    avobenzone, octocrylene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE10 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE22 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-000-011 in 1 CARTON01/01/2017
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-000-021 in 1 CARTON01/01/2017
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only01/01/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC.624244349manufacture(49967-000) , pack(49967-000)