Label: LOREAL PARIS INFALLIBLE UP TO 24 H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN- octinoxate and titanium dioxide liquid

  • NDC Code(s): 49967-009-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Active ingredients

    Octinoxate 6.7%

    Titanium dioxide 3.6%

  • Purpose

    Sunscreen

  • Uses

    - helps prevent sunburn

    - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only

  • Flammable until dry.

    Do not use near fire, flame or heat.

  • Do not use

    on damaged or broken skin

  • When using this product

     keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    rash occurs

  • Keep out of reach of children.

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

  • Directions

    For sunscreen use:

    ● shake well

    ● apply liberally 15 minutes before sun exposure

    ● reapply at least every 2 hours

    ● use a water resistant sunscreen if swimming or sweating

    ● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    ● limit time in the sun, especially from 10 a.m. – 2 p.m.

    ● wear long-sleeved shirts, pants, hats, and sunglasses

    ● children under 6 months of age: Ask a doctor

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, disteardimonium hectorite, HDI/trimethylol hexyllactone crosspolymer, bis-PEG/PPG-14/14 dimethicone, magnesium sulfate, aluminum hydroxide, phenoxyethanol, disodium stearoyl glutamate, hydrogen dimethicone, dipentaerythrityl tetrahydroxystearate/tetraisostearate, fragrance, silica silylate, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, tocopherol, hexyl cinnamal, silica, isobutane, benzyl salicylate, linalool, alpha-isomethyl ionone, benzyl alcohol, BHT, citronellol, may contain: titanium dioxide, iron oxides, ferric ammonium ferrocyanide

  • Questions or comments?

    1-800-322-2036

    Monday - Friday

    (10 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of front label

    image of front label
  • PRINCIPAL DISPLAY PANEL

    image of back label

    image of back label
  • INGREDIENTS AND APPEARANCE
    LOREAL PARIS INFALLIBLE UP TO 24 H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN 
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE36 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALCOHOL (UNII: 3K9958V90M)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PERLITE (UNII: 0SG101ZGK9)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    NYLON-12 (UNII: 446U8J075B)  
    ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOBUTANE (UNII: BXR49TP611)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-009-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2018
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.624244349manufacture(49967-009)
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