LA ROCHEPOSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]

LA ROCHEPOSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-090-01
Set ID 52d494ac-59dd-405d-9d78-5c768de01c39
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Titanium dioxide 11%

  • Warnings

    For external use only

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    rash or irritation develops and lasts

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well before use
    • apply evenly before sun exposure
    • reapply as needed or after towel drying, swimming, or perspiring
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    water, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, protpylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, PEG-9

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 40 minutes of activity in the water or perspiring

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    LA ROCHEPOSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    UNDECANE (UNII: JV0QT00NUE)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    NYLON-12 (UNII: 446U8J075B)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    TRIDECANE (UNII: A3LZF0L939)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    TALC (UNII: 7SEV7J4R1U)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-090-011 in 1 CARTON07/01/201111/28/2014
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2011
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodier Cosmetics LP007317209manufacture(49967-090)

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