Drug Facts

CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN 050 IVORY- 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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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, no skin cancer or early skin aging.

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

aqua/water/eau, cyclopentasiloxane, neopentyl glycol diethylhexanoate, butylene glycol, hdi/trimethylol 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, retinyl palmitate, sodium hyaluronate, tocopheryl acetate, silica, disodium stearoyl glutamate, ascorbyl glucoside, sorbic acid, alaria esculenta extract, tocopherol, bht, [may contain: iron oxides]

Outer Carton

Top Label

Base Labels

CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN 050 IVORY
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66184-401
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.302 g in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.606 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:66184-401-02	1 in 1 BOX
1	NDC:66184-401-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2013

Labeler - Coty US LLC (789573201)

Registrant - Coty Inc. (958662223)

Name	Address	ID/FEI	Business Operations
Establishment
Lancaster		401011325	manufacture(66184-401)