Label: SOORYEHAN BICHAEK JADAN SUN- zinc oxide, titanium dioxide, phenylbenzimidazole sulfonic acid 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 June 1, 2010

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  • ACTIVE INGREDIENT

    ZINC OXIDE  12.88mL/100mL

    TITANIUM DIOXIDE  40.32mL/100mL

    ENSULIZOLE  3.9mL/100mL

  • 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

    Sooryehan

    Sun Cream

    SPF 45 / PA+++

    jadansuncream

  • INGREDIENTS AND APPEARANCE
    SOORYEHAN BICHAEK JADAN SUN 
    zinc oxide, titanium dioxide, phenylbenzimidazole sulfonic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-447
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.88   in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.32 mL  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.9 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-447-021 in 1 BOX
    1NDC:53208-447-0170 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/24/2010
    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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