YVES SAINT LAURENT TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION BROAD SPECTRUM SPF 22 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]

YVES SAINT LAURENT TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION BROAD SPECTRUM SPF 22 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-787-01, 49967-787-02, 49967-787-03, 49967-787-04
Set ID 6c8f7aa2-ce4a-4720-ae5e-dd33c48f2e5e
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Octinoxate 6.8%

  • 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

  • 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

    water, cyclopentasiloxane, glycerin, dimethicone, isododecane, PEG-10 dimethicone, sorbitol, bis-PEG/PPG-14/14 dimethicone, synthetic fluorphlogopite, sodium chloride, silica, dimethicone/polyglycerin-3 crosspolymer, phenoxyethanol, methyl methacrylate crosspolymer, capryly glycol, disodium stearoyl glutamate, disteardimonium hectorite, silica silylate, tocopheryl acetate, ethylhexylglycerin, fragrance, aluminum hydroxide, ascorbyl palmitate, ethylhexyl hydroxystearate, triethoxycaprylylsilane, dipropylene glycol, ruscus aculeatus root extract, BHT, tocopherol, sodium citrate, isopropyl alcohol ; may contain : titanium dioxide, iron oxides, bismuth oxychloride

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    YVES SAINT LAURENT TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION BROAD SPECTRUM SPF 22 SUNSCREEN 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-787
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE68 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SORBITOL (UNII: 506T60A25R)  
    BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-787-011 in 1 CARTON07/01/2015
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:49967-787-021 in 1 CARTON07/01/2015
    210 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49967-787-031 mL in 1 PACKET; Type 0: Not a Combination Product07/01/2015
    4NDC:49967-787-04125 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2015
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sicos et Cie276993581manufacture(49967-787) , pack(49967-787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Biocosm SARL288479491pack(49967-787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(49967-787)

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