Active Ingredients

CK ONE AIRLIGHT PRESSED POWDER SPF 15 HONEY 600- titanium dioxide powder
Coty US LLC

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.

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Active Ingredients

Titanium Dioxide 14.75%

Zinc Oxide 1%

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]

airlight_product

baselabel_honey

airlight pp_drug facts

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66184-515
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:66184-515-01	10 g in 1 CARTRIDGE
2	NDC:66184-515-02	10 g in 1 BOX

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/24/2012

Labeler - Coty US LLC (789573201)

Registrant - Coty Inc. (958662223)

Name	Address	ID/FEI	Business Operations
Establishment
Intercos Europe S.p.A.		438961310	manufacture(66184-515)