CK ONE WATERFRESH FACE MAKEUP SPF 15 350 BEIGE- titanium dioxide cream

ck one waterfresh face makeup spf 15 by

Drug Labeling and Warnings

ck one waterfresh face makeup spf 15 by is a Otc medication manufactured, distributed, or labeled by Coty US LLC, Coty Inc., Intercos Europe S.p.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 2.5%

Titanium dioxide 5.0%

PURPOSE

Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach 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 int he 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 external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

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

aqua/water/eau, hydogentated polyisobutene, isohexadecane, dextrin palmitate, butylene glycol, hydrogenated lecithin, alcohol, triethylhexanoin, quaternium-90, bentonite, pentylene glycol, glycerin, peg-15/lauryl dimethicone crosspolymer, stearoyl inulin, phenoxyethanol, isopropl titanium triisostearate, octyldodectl pca, lysine, isododecane, dipropylene glycol, magnesium chloride, sodium chloride, sodium citrate, may contain: iron oxides, titanium dioxide, mica.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CK ONE WATERFRESH FACE MAKEUP SPF 15   350 BEIGE
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66184-455
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	4.95 mL  in 9.9 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	2.4 mL  in 9.9 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isohexadecane (UNII: 918X1OUF1E)
Butylene Glycol (UNII: 3XUS85K0RA)
Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N)
Alcohol (UNII: 3K9958V90M)
Triethylhexanoin (UNII: 7K3W1BIU6K)
Pentylene Glycol (UNII: 50C1307PZG)
Glycerin (UNII: PDC6A3C0OX)
Lysine (UNII: K3Z4F929H6)
Isododecane (UNII: A8289P68Y2)
Dipropylene Glycol (UNII: E107L85C40)
Magnesium Chloride (UNII: 02F3473H9O)
Sodium Chloride (UNII: 451W47IQ8X)
Potassium Chloride (UNII: 660YQ98I10)
Sodium Citrate (UNII: 1Q73Q2JULR)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66184-455-01	9.9 g in 1 CARTRIDGE
2	NDC: 66184-455-02	9.9 g in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/23/2012

Labeler - Coty US LLC (789573201)

Registrant - Coty Inc. (958662223)

Establishment
Name	Address	ID/FEI	Business Operations
Intercos Europe S.p.A.		438961310	manufacture