Label: CK ONE WATERFRESH FACE MAKEUP SPF 15 600 HONEY- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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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  • 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

    waterfresh_product

  • PRINCIPAL DISPLAY PANEL

    baselabel_honey

  • PRINCIPAL DISPLAY PANEL

    waterfresh_carton

  • INGREDIENTS AND APPEARANCE
    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
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