Label: SOORYEHAN JADAN SUN MILD- octocrylene, zinc oxide, octinoxate, 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 May 20, 2010

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  • ACTIVE INGREDIENT

    ZINC OXIDE  5.612mL/100mL

    OCTINOXATE  7mL/100mL

    OCTOCRYLENE  2mL/100mL

    TITANIUM DIOXIDE  2mL/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 Mild

    SPF 45/PA++

    mildcream

  • INGREDIENTS AND APPEARANCE
    SOORYEHAN JADAN SUN MILD  
    octocrylene, zinc oxide, octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-446
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.612 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2   in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-446-021 in 1 BOX
    1NDC:53208-446-01100 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35805/20/2010
    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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