Label: 3CE SKIN TONE CONTROL PRIMER ICE VANILLA- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 14, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 3.1%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycol, Triethylhexanoin, Titanium Dioxide (CI 77891), Phenyl Trimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Cyclopentasiloxane, Silica, Mica (CI 77019), Cetyl Dimethicone, Cetearyl Alcohol, Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Glyceryl Stearate, PEG-2 Stearate, PEG-100 Stearate, Dimethicone Crosspolymer, Sodium Polyacrylate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77492), Isohexadecane, Laureth-4, Laureth-23,Ethylhexylglycerin, Fragrance(Parfum), Xanthan Gum, Polysorbate 80, Chromium Oxide Greens (CI 77288)

  • PURPOSE

    Purpose: Skin Protectant

  • CAUTION

    CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

  • KEEP OUT OF REACH OF CHILDREN

    keep it out of children's reach

  • INSTRUCTIONS

    INSTRUCTIONS: This primer helps foundation adhere better on skin and lengthens the longevity of the foundation. Moreover, it gives a brighter skin tone so that you can have a better finish

  • Directions

    Directions: Apply basic makeup such as moisturizer and sunscreen. Then, place primer on face by using a makeup brush or sponge. Pat on lightly for a smooth finish.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE SKIN TONE CONTROL PRIMER ICE VANILLA 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.93 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-126-021 in 1 CARTON08/01/2016
    1NDC:60764-126-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-126)
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