Label: DONGINBI RED GINSENG PERFECT SUN- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 8, 2015

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  • ACTIVE INGREDIENT

    titanium dioxide


  • INACTIVE INGREDIENT

    water, butylene glycol, glycerin, dimethicone, zinc oxide, stearic acid, ginsenosides, honey ext, butylparaben, etc


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    following the use of base or foundation, take a suitable amount with puff and apply thinly over the entire face


  • WARNINGS

    ・Stop using the product when you have skin problems or the product disagrees with your skin
    ・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
    ・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DONGINBI RED GINSENG PERFECT SUN 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69640-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.905 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69640-3001-136 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/08/2015
    Labeler - KGC Life&Gin Co., Ltd. (689680259)
    Registrant - KGC Life&Gin Co., Ltd. (689680259)
    Establishment
    NameAddressID/FEIBusiness Operations
    KGC Life&Gin Co., Ltd.689680259manufacture(69640-3001)
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