Label: 3CE LIP COLOR 401 SCANDAL- titanium dioxide lipstick

  • 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 October 5, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 1.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Triethylhexanoin, Polyglyceryl-2 Triisostearate, Trimethylolpropane Tricaprylate/Tricaprate, Isononyl Isononanoate, Mica (CI 77019), Diisostearyl Malate, Diglyceryl Sebacate/Isopalmitate, Silica, Ceresin, Ozokerite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Pentaerythrityl Tetraisostearate, Red 6 (CI 15850), Red 28 Lake (CI 45410), VP/Hexadecene Copolymer, Microcrystalline Wax, Sorbitan Isostearate, Silica Silylate, Polyethylene, Synthetic Wax, Silica Dimethyl Silylate, Polyglyceryl-2 Diisostearate, Methicone, Ethylene/Propylene Copolymer, Cholesteryl Macadamiate, Methylparaben, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea) Butter, Water, Butylene Glycol, Diamond powder, Amethyst Powder, Pearl Powder, Tourmaline

  • PURPOSE

    Purpose: Sunscreen

  • 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

  • DESCRIPTION

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

    Directions: Twist to dispense makeup and apply evenly to lips

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE LIP COLOR 401 SCANDAL 
    titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.05 g  in 3.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Triethylhexanoin (UNII: 7K3W1BIU6K)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-069-021 in 1 CARTON08/01/2016
    1NDC:60764-069-013.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-069)