YVES SAINT LAURENT ALL HOURS FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]

YVES SAINT LAURENT ALL HOURS FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-362-01, 49967-362-02, 49967-362-03, 49967-362-04, 49967-362-05, 49967-362-06
Set ID 622b5def-c0ae-4269-9358-ec3c9c65a975
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

  • 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, cyclopentasiloxane, alcohol denat., isododecane, acrylates/polytrimethylsiloxymethacrylate copolymer, butylene glycol, glycerin, polymethylsilsesquioxane, cetyl PEG/PPG-10/1 dimethicone, synthetic fluorphlogopite, isohexadecane, polyglyceryl-4 isostearate, magnesium sulfate, disodium stearoyl glutamate, fragrance, perlite, saccharomyces/xylinum/black tea ferment, silica silylate, aluminum hydroxide, butyrospermum parkii (shea) seedcake extract, hydroxyethylcellulose, BHT, phenoxyethanol, sodium citrate, benzyl alcohol, linalool, citric acid, potassium sorbate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, biotin; may contain: titanium dioxide, iron oxides

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    YVES SAINT LAURENT ALL HOURS FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-362
    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
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    PERLITE (UNII: 0SG101ZGK9)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    BIOTIN (UNII: 6SO6U10H04)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-362-011 in 1 CARTON06/01/2017
    125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-362-02125 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
    3NDC:49967-362-031 in 1 CARTON06/01/2017
    310 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:49967-362-041 in 1 CARTON06/01/2017
    45 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:49967-362-051 mL in 1 PACKET; Type 0: Not a Combination Product06/01/2017
    6NDC:49967-362-061.2 mL in 1 BLISTER PACK; Type 0: Not a Combination Product02/08/2019
    7NDC:49967-362-071 in 1 CARTON07/30/2020
    78 mL in 1 BOTTLE; Type 0: Not a Combination Product
    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(49967-362) , pack(49967-362)
    Establishment
    NameAddressID/FEIBusiness Operations
    BPS60272259304pack(49967-362)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(49967-362)

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