CK ONE AIRLIGHT PRESSED POWDER SPF 15 TAN 500- titanium dioxide powder

ck one airlight pressed powder spf 15 by

Drug Labeling and Warnings

ck one airlight pressed powder spf 15 by is a Otc medication manufactured, distributed, or labeled by Coty US LLC, Coty Inc., Intercos Europe S.p.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CK ONE AIRLIGHT PRESSED POWDER SPF 15  TAN 500
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66184-510
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: 66184-510-01	10 g in 1 CARTRIDGE
2	NDC: 66184-510-02	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(66184-510)