Label: 3 CONCEPT EYES HONEY FACE CHIFFON FLUID 001- 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 3, 2013

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

  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 9.294%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cyclopentasiloxane, Glycerin, Butylene Glycol,Isononyl Isononanoate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Iron Oxides (CI 77492), Neopentyl, Sodium Chloride, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Mica (CI 77019), Butyrospermum Parkii (Shea) Butter, Isostearic Acid, Polymethylsilsesquioxane, Aluminum Stearate, Stearic Acid, Iron Oxides (CI 77491), Dextrin Palmitate, Dextrin Palmitate/Ethylhexanoate, Methylparaben, Chlorphenesin, Triethoxycaprylylsilane, Aluminum Hydroxide, Iron Oxides (CI 77499), Palmitic Acid, Propylparaben, Camellia Sinensis Leaf Extract, Disodium EDTA, Portulaca Oleracea Extract, Phenoxyethanol

  • 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 Put the suitable amount of foundation on a sponge or a foundation brush, and apply it evenly on your face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3 CONCEPT EYES HONEY FACE CHIFFON FLUID 001 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.71 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-005-0140 mL 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(60764-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689019313manufacture(60764-005)