CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN- titanium dioxide liquid 
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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Drug Facts

Octinoxate 2.0%

Titanium Dioxide 2.5%

Sunscreen

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

Helps prevent sunburn

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.

For sunscreen use:

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.

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CK ONE 3-IN-1 FACE MAKEUP  WITH SPF 8 SUNSCREEN
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-405
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:66184-405-0130 mL in 1 CONTAINER
2NDC:66184-405-0230 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

Revised: 12/2011
Document Id: 240a0a22-eb1c-4884-a4f0-a6e94b69696b
Set id: d5c80339-1fbc-435c-b786-f7dfef7f2832
Version: 1
Effective Time: 20111208
 
Coty US LLC