Drug Facts

CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN - titanium dioxide and octinoxate 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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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:

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: ask a doctor

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66184-420
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	7.5 mL in 30 mL
Octinoxate (Octinoxate)	Octinoxate	0.6 mL in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Cyclomethicone 5
Neopentyl Glycol
Butylene Glycol
PEG-10 Dimethicone (600 CST)
Tricaprin
Phenoxyethanol
Methyl Methacrylate
Caprylyl Glycol
Aluminum Dimyristate
Triethoxycaprylylsilane
Vitamin A Palmitate
Hyaluronate Sodium
Alpha-Tocopherol Acetate
Silicon Dioxide
Disodium Stearoyl Glutamate
Sorbic Acid
Alaria Esculenta
Tocopherol
Butylated Hydroxytoluene

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:66184-420-01	30 mL in 1 CONTAINER	None
2	NDC:66184-420-02	30 mL in 1 BOX	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2012

Labeler - Coty US LLC (789573201)

Registrant - Coty Inc. (958662223)

Establishment
Name	Address	ID/FEI	Operations
Lancaster S.A.M.		401011325	manufacture

Revised: 12/2011 Coty US LLC