CK ONE WATERFRESH FACE MAKEUP SPF 15  600 HONEY- titanium dioxide cream 
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 2.5%

Titanium dioxide 5.0%

Sunscreen

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

Helps prevent sunburn

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.


For sunscreen use:


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.

waterfresh_product

baselabel_honey

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CK ONE WATERFRESH FACE MAKEUP SPF 15   600 HONEY
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-475
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide4.95 mL  in 9.9 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate2.4 mL  in 9.9 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66184-475-019.9 g in 1 CARTRIDGE
2NDC:66184-475-029.9 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/23/2012
Labeler - Coty US LLC (789573201)
Registrant - Coty Inc. (958662223)
Establishment
NameAddressID/FEIBusiness Operations
Intercos Europe S.p.A.438961310manufacture

Revised: 1/2012
Document Id: 2d916e0f-0dd1-416f-8f92-9d5186c2eca9
Set id: 4f0e14a9-11ae-44d5-b47a-04fea16bb821
Version: 1
Effective Time: 20120123
 
Coty US LLC