CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN- titanium dioxide liquid

ck one3-in-1face makeup by

Drug Labeling and Warnings

ck one3-in-1face makeup by is a Otc medication manufactured, distributed, or labeled by Coty US LLC, Coty Inc., Lancaster S.A.M.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 2.0%

Titanium Dioxide 2.5%

PURPOSE

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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
  

INACTIVE INGREDIENT

water, cyclopentasiloxane, neopentyl, glycol diethylhexanoate, butylene glycol, hdi/trimethylol hexyllactone crosspolymer, mica, glycern, 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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CK ONE3-IN-1FACE MAKEUP  WITH SPF8 SUNSCREEN
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66184-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7.5 mL  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.6 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66184-400-01	30 mL in 1 CONTAINER
2	NDC: 66184-400-02	30 mL in 1 BOX

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	Business Operations
Lancaster S.A.M.		401011325	manufacture