Label: CK ONE AIRLIGHT PRESSED POWDER SPF 15 HONEY 600- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 66184-515-01, 66184-515-02 - Packager: Coty US LLC
- 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CK ONE AIRLIGHT PRESSED POWDER SPF 15 HONEY 600
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-515 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Oxide 100 mg in 10 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:66184-515-01 10 g in 1 CARTRIDGE 2 NDC:66184-515-02 10 g in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/24/2012 Labeler - Coty US LLC (789573201) Registrant - Coty Inc. (958662223) Establishment Name Address ID/FEI Business Operations Intercos Europe S.p.A. 438961310 manufacture(66184-515)