ck one3-in-1face makeup with SPF8 sunscreen

Dosage form: liquid
Ingredients: Titanium Dioxide 7.5mL in 30mL, Octinoxate 0.6mL in 30mL
Labeler: Coty US LLC
NDC Code: 66184-400

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 2.0%

Titanium Dioxide 2.5%

Sunscreen

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

Helps prevent sunburn.

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.

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

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.

CK ONE3-IN-1FACE MAKEUP  WITH SPF8 SUNSCREEN
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide7.5 mL  in 30 mL
Octinoxate (Octinoxate) Octinoxate0.6 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cyclomethicone 5 
Neopentyl Glycol 
Butylene Glycol 
PEG-10 DIMETHICONE (600 CST) 
Tricaprin 
Phenoxyethanol 
Methyl Methacrylate 
Caprylyl Glycol 
Aluminum Dimyristate 
Triethoxycaprylylsilane 
Vitamin A Palmitate 
Hyaluronate Sodium 
Alpha-Tocopherol Acetate 
Silicon Dioxide 
Disodium Stearoyl Glutamate  
Sorbic Acid 
Alaria Esculenta 
Tocopherol 
Butylated Hydroxytoluene 
Packaging
#Item CodePackage Description
1NDC:66184-400-0130 mL in 1 CONTAINER
2NDC:66184-400-0230 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2012
Labeler - Coty US LLC (789573201)
Registrant - Coty Inc. (958662223)
Establishment
NameAddressID/FEIOperations
Lancaster S.A.M.401011325manufacture

Revised: 12/2011
 
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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