YVES SAINT LAURENT LE TEINT ENCRE DE PEAU FUSION INK FOUNDATION BROAD SPECTRUM SPF 18 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]

YVES SAINT LAURENT LE TEINT ENCRE DE PEAU FUSION INK FOUNDATION BROAD SPECTRUM SPF 18 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-789-01, 49967-789-02, 49967-789-03
Set ID 8f18e74b-b903-429a-a3fb-9d233f7719b6
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Octinoxate 3%

  • 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

  • Caution:

    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 generously 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

    dimethicone, cyclohexasiloxane, isododecane, alcohol denat., vinyl dimethicone/methicone silsesquioxane crosspolymer, phenyl trimethicone, disteardimonium hectorite, PEG-10 dimethicone, synthetic fluorphlogopite, water, propylene carbonate, disodium stearoyl glutamate, silica silylate, fragrance, calophyllum inophyllum seed oil, aluminum hydroxide, benzyl alcohol; may contain: titanium dioxide, iron oxides

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    YVES SAINT LAURENT LE TEINT ENCRE DE PEAU FUSION INK FOUNDATION BROAD SPECTRUM SPF 18 SUNSCREEN 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-789
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALCOHOL (UNII: 3K9958V90M)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-789-011 in 1 CARTON08/01/2014
    125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-789-021 in 1 CARTON08/01/2014
    210 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49967-789-030.27 mL in 1 PACKAGE; Type 0: Not a Combination Product08/01/201411/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sicos et Cie276993581manufacture(49967-789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Biocosm SARL288479491pack(49967-789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(49967-789)

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