Medication Guide App

ck one waterfresh face makeup spf 15 600 honey

Dosage form: cream
Ingredients: Titanium Dioxide 4.95mL in 9.9g, Octinoxate 2.4mL in 9.9g
Labeler: Coty US LLC
NDC Code: 66184-475

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 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:


  • 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

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.

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide4.95 mL  in 9.9 g
Octinoxate (Octinoxate) Octinoxate2.4 mL  in 9.9 g
Inactive Ingredients
Ingredient NameStrength
Water 
Isohexadecane 
Butylene Glycol  
Hydrogenated Soybean Lecithin  
Alcohol  
Triethylhexanoin  
Pentylene Glycol  
Glycerin  
Lysine  
Isododecane  
Dipropylene Glycol  
Magnesium Chloride  
Sodium Chloride  
Potassium Chloride  
Sodium Citrate  
Mica  
Packaging
#Item CodePackage Description
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/FEIOperations
Intercos Europe S.p.A.438961310manufacture

Revised: 01/2012
 
Coty US LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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