Label: THE HISTORY OF WHOO GONGJINHYANG SEOL WHITENING SUN- zinc oxide, ensulizole, polysilicone-15, titanium dioxide, atractylodes japonica root oil 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 April 22, 2011

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  • ACTIVE INGREDIENT

    ZINC OXIDE               6.117%
    ENSULIZOLE             3.9%
    POLYSILICONE-15     3%
    TITANIUM DIOXIDE    2.48%
    ATRACTYLODES JAPONICA ROOT OIL    0.05%

  • WARNINGS AND PRECAUTIONS


    For external use only

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING


    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • PRINCIPAL DISPLAY PANEL

    WHOO GONGJINHYANG SEOL WHITENING SUN CREAM

  • INGREDIENTS AND APPEARANCE
    THE HISTORY OF WHOO GONGJINHYANG SEOL WHITENING SUN 
    zinc oxide, ensulizole, polysilicone-15, titanium dioxide, atractylodes japonica root oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-525
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.117 mL  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.9 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.48 mL  in 100 mL
    ATRACTYLODES JAPONICA ROOT OIL (UNII: EC228KGY00) (ATRACTYLODES JAPONICA ROOT OIL - UNII:EC228KGY00) ATRACTYLODES JAPONICA ROOT OIL0.05 mL  in 100 mL
    POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29) POLYSILICONE-153 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HECTORITE (UNII: 08X4KI73EZ)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    ACETATE ION (UNII: 569DQM74SC)  
    MICA (UNII: V8A1AW0880)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIOSMETIN (UNII: TWZ37241OT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-525-021 in 1 BOX
    1NDC:53208-525-0145 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/24/2011
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture
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