Label: 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION MILK IVORY- 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 October 2, 2013

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

  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 3.615%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol,Ethylhexyl Methoxycinnamate , Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Zinc Oxide (CI 77947), Glycerin, Trimethylsiloxysilicate, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Mica (CI 77019), Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Cyclomethicone, Disteardimonium Hectorite, Sorbitan Isostearate, Iron Oxides (CI 77492), Tribehenin, HDI/Trimethylol Hexyllactone Crosspolymer, Phenyl Trimethicone, Phenoxyethanol, Dimethicone Crosspolymer, Triethoxycaprylylsilane, Glyceryl Behenate,Polyglyceryl-6 Octastearate, Iron Oxides (CI 77491), Dimethicone, Disodium EDTA, Iron Oxides (CI 77499), Ethylhexylglycerin, Silica

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: Keep out of eyes. Stop use if irritation occurs. Keep out of reach of babies and children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children.

  • INDICATIONS AND USAGE

    Indication and usage: 1. Always close the lid after use. 2. Keep this product in the room temperature.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration: Shake foundation enough to be mixed before use, and apply suitable amount of it on your face evenly with a foundation brush.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION MILK IVORY 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.44 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-001-0140 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2013
    Labeler - NANDA CO., LTD. (557816075)
    Registrant - NANDA CO., LTD. (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANDA CO., LTD.557816075repack(60764-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689019313manufacture(60764-001)