Label: CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN- titanium dioxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 8, 2011

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  • ACTIVE INGREDIENT

    Octinoxate 2.0%

    Titanium Dioxide 2.5%

  • PURPOSE

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • WARNINGS

    Skin cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • DOSAGE & ADMINISTRATION

    For sunscreen use:

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor
  • INACTIVE INGREDIENT

    water, cyclopentasiloxane, neopentyl, glycol diethylhexanoate, butylene glycol, hdi/trimethylol hexyllactone crosspolymer, mica, glycerin, vinyl dimethicone/methicone silsesquioxane crosspolymer, peg-10 dimethicone, caprylic/capric triglyceride, disteardimonium hectorite, phenoxyethanol, methyl methacrylate crosspolymer, caprylyl glycol, aluminum dimyristate, triethoxycaprylylsilane, parfum/fragrance, retynyl palmitate, sodium hyaluronate, tocopheryl acetate, silica, disodium stearoyl glutamate, ascorbyl glucoside, sorbic acid, alaria esculenta extract, tocopherol, bht, may contain: iron oxides.

  • PRINCIPAL DISPLAY PANEL

    Top Label_300

  • PRINCIPAL DISPLAY PANEL

    Base Label_300

  • PRINCIPAL DISPLAY PANEL

    Bottle_300

  • PRINCIPAL DISPLAY PANEL

    outer carton

  • INGREDIENTS AND APPEARANCE
    CK ONE 3-IN-1 FACE MAKEUP  WITH SPF 8 SUNSCREEN
    titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide7.5 mL  in 30 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.6 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Neopentyl Glycol (UNII: QI80HXD6S5)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
    Tricaprin (UNII: O1PB8EU98M)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methyl Methacrylate (UNII: 196OC77688)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Aluminum Dimyristate (UNII: J2KA067N9O)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Disodium Stearoyl Glutamate (UNII: 45ASM2L11M)  
    Sorbic Acid (UNII: X045WJ989B)  
    Alaria Esculenta (UNII: EJ9JK8J58D)  
    Tocopherol (UNII: R0ZB2556P8)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-410-0130 mL in 1 CONTAINER
    2NDC:66184-410-0230 mL in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2012
    Labeler - Coty US LLC (789573201)
    Registrant - Coty Inc. (958662223)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lancaster S.A.M.401011325manufacture
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