Label: 3CE LIP COLOR 906 BITE IT- triethylhexanoin lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 30, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Triethylhexanoin 9.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Polyglyceryl-2 Triisostearate, Diisostearyl Malate, Red 40 Lake (CI 16035), Caprylic/Capric Triglyceride, PentaerythritylTetraethylhexanoate, Ozokerite, DiglycerylSebacate/Isopalmitate, Petrolatum, Ceresin, Bis-Diglyceryl Polyacyladipate-2, Talc, Polyethylene, GlycerylEthylhexanoate/Stearate/Adipate, Dicalcium Phosphate, Euphorbia Cerifera (Candelilla) Wax, Mica (CI 77019), Methyl Methacrylate Crosspolymer, Silica, Red 33 Lake (CI 17200), Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Vinyl Dimethicone/MethiconeSilsesquioxaneCrosspolymer, SorbitanIsostearate, Hydrogenated Vegetable Oil, RicinusCommunis (Castor) Seed Oil, Blue 1 Lake (CI 42090), Methicone, Tocopheryl Acetate, PhytosterylMacadamiate, Iron Oxides (CI 77499), MangiferaIndica (Mango) Seed Butter, ButyrospermumParkii (Shea) Butter, Diamond powder, Water, Butylene Glycol, Amethyst Powder, Pearl Powder, Tourmaline, Methylparaben

  • PURPOSE

    Purpose: Lip color

  • 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: A rich color lipstick that moistly adheres to lips.

  • Directions

    Directions: Twist to dispense makeup and apply evenly to lips

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE LIP COLOR 906 BITE IT 
    triethylhexanoin lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triethylhexanoin (UNII: 7K3W1BIU6K) (Triethylhexanoin - UNII:7K3W1BIU6K) Triethylhexanoin0.31 g  in 3.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Diisostearyl Malate (UNII: QBS8A3XZGQ)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-050-021 in 1 CARTON08/01/2016
    1NDC:60764-050-013.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-050)