Label: 3CE MATTE LIP CRAYON DUBIOUS- dimethicone 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 October 11, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 0.6%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Isoamyl Laurate, Polyglyceryl-2 Triisostearate, Ceresin, Mica, Silica, Euphorbia Cerifera (Candelilla) Wax, Red 7 Lake (CI 15850), Polyethylene, Red 27 Lake (CI 45410), Iron Oxides (CI 77499), Dimethicone/Vinyl DimethiconeCrosspolymer, Iron Oxides (CI 77491), Propylparaben, SimmondsiaChinensis (Jojoba) Seed Oil, PerseaGratissima (Avocado) Oil

  • PURPOSE

    Purpose: Lip Crayon

  • 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: Powdery finish matte lip crayon adheres smoothly onto your lips and imparts a non-oily finish for a chic look.

  • Directions

    Directions: Glide across the entire lip with powdery finish matte lip crayon and apply it again to the center of your lips to get voluminous and fuller lips

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE MATTE LIP CRAYON DUBIOUS 
    dimethicone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-084
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.006 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Isoamyl Laurate (UNII: M1SLX00M3M)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-084-021 in 1 CARTON08/10/2016
    1NDC:60764-084-011 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/10/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075manufacture(60764-084)