YVES SAINT LAURENT TOP SECRETS CC PRIMER COLOR CORRECTING PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC.]

YVES SAINT LAURENT TOP SECRETS CC PRIMER COLOR CORRECTING PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC.]
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NDC 49967-674-01, 49967-674-02
Set ID d53effa1-b5b2-49a5-90b8-8fe676c3a20d
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Octinoxate 5%

    Titanium dioxide 6.3%

  • 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

  • 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, dimethicone, glycerin, alcohol denat., isododecane, PEG-10 dimethicone, dipropylene glycol, pentylene glycol, disteardimonium hectorite, betaine, talc, diisostearyl malate, fragrance, tocopheryl acetate, macadamia ternifolia seed oil, hydroxypropyl tetrahydropyrantriol, hydrolyzed prunus domestica, phenoxyethanol, adenosine, magnesium sulfate, magnesium aspartate, ethylhexyl hydroxystearate, ethyl menthane carboxamide, silica, dimethiconol, dimethicone/vinyl dimethicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, tin oxide, linalool, propylene glycol, copper gluconate, coriandrum sativum (coriander) fruit oil, moringa pterygosperma seed extract, carrageenan, passiflora edulis seed oil, disodium stearoyl glutamate, disodium phosphate, butylene glycol, BHT, citric acid, methicone, prunus armeniaca (apricot) kernel oil, aluminum starch octenylsuccinate, alumina, aluminum hydroxide; may contain: mica, red 28 lake, red 7, iron oxides, carmine, ferric ammonium ferrocyanide, bismuth oxychloride, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    YVES SAINT LAURENT TOP SECRETS CC PRIMER COLOR CORRECTING PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN 
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-674
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE63 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BETAINE (UNII: 3SCV180C9W)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ADENOSINE (UNII: K72T3FS567)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    MORINGA OLEIFERA SEED (UNII: TIX5482832)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-674-011 in 1 CARTON03/01/2017
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-674-021 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2017
    Labeler - L'Oreal USA Products Inc. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    SICOS ET CIE276993581manufacture(49967-674) , pack(49967-674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Biocosm SARL288479491pack(49967-674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(49967-674)

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