Label: CK ONE AIRLIGHT PRESSED POWDER SPF 15 HONEY 600- titanium dioxide powder

  • 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 November 19, 2013

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  • ACTIVE INGREDIENT

    Titanium Dioxide 14.75%

    Zinc Oxide 1%

  • INACTIVE INGREDIENT

    Talc, Dimethicone, Polymethylsilsequioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Zinc Stearate, Silica, Phenyl Trimthicone, Synthetic Fluorphlogopite, Caprylyl Methicone, Caprylyl Glycol, Methicone, Zea Mays (Corn) sTarch, Phenoxyethanol, Hyxylene Glycol, [May contain: Iron Oxides, Mica]

  • PRINCIPAL DISPLAY PANEL

    airlight_product

  • PRINCIPAL DISPLAY PANEL

    baselabel_honey

  • PRINCIPAL DISPLAY PANEL

    airlight pp_drug facts

  • INGREDIENTS AND APPEARANCE
    CK ONE AIRLIGHT PRESSED POWDER SPF 15  HONEY 600
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 1.475 mg  in 10 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    Talc (UNII: 7SEV7J4R1U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Starch, corn (UNII: O8232NY3SJ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Mica (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-515-0110 g in 1 CARTRIDGE
    2NDC:66184-515-0210 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/24/2012
    Labeler - Coty US LLC (789573201)
    Registrant - Coty Inc. (958662223)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intercos Europe S.p.A.438961310manufacture(66184-515)