Label: CK ONE WATERFRESH FACE MAKEUP SPF 15 600 HONEY- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 66184-475-01, 66184-475-02 - Packager: Coty US LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 23, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
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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
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INGREDIENTS AND APPEARANCE
CK ONE WATERFRESH FACE MAKEUP SPF 15 600 HONEY
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-475 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:66184-475-01 9.9 g in 1 CARTRIDGE 2 NDC:66184-475-02 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