YVES SAINT LAURENT ALL HOURS PRIMER BROAD SPECTRUM SPF 18 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]

YVES SAINT LAURENT ALL HOURS PRIMER BROAD SPECTRUM SPF 18 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-403-01, 49967-403-02
Set ID 2dc9c98e-eecb-4537-9fc0-af95cdff616f
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Octinoxate 6.5%

  • 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.

    Avoid fire, flame and heat during application.

  • 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 before use
    • 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, trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, titanium dioxide, perlite, nylon-12, lauryl methacrylate/glycol dimethacrlyate crosspolymer, HDI/trimethylol hexyllactone crosspolymer, bismuth oxychloride, BIS-PEG/PPG-14/14 dimethicone, magnesium sulfate, silica silylate, phenoxyethanol, disteardimonium hectorite, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, hydrogen dimethicone, tocopherol, propylene glycol, silica, iron oxides, BHT, synthetic fluorphlogopite, rosa centifolia flower extract, disodium stearoyl glutamate

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    YVES SAINT LAURENT ALL HOURS PRIMER BROAD SPECTRUM SPF 18 SUNSCREEN 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PERLITE (UNII: 0SG101ZGK9)  
    NYLON-12 (UNII: 446U8J075B)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-403-011 in 1 CARTON06/01/2017
    140 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-403-021 mL in 1 PACKET; Type 0: Not a Combination Product06/01/201711/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    SICOS ET CIE276993581manufacture(49967-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    BPS60272259304pack(49967-403)

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