Label: OHUI SUNSCIENCE LUMINOUS WHITENING SUNBLOCK- ensulizole, octisalate, bemotrizinol, octocrylene, diethylamino hydroxybenzoyl hexyl benzoate, zinc oxide, 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 7, 2011

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

  • ACTIVE INGREDIENT

    ENSULIZOLE 3.9%
    OCTISALATE 4.7%
    BEMOTRIZINOL 1.5%
    OCTOCRYLENE 5%
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 1%
    ZINC OXIDE 12.3%
    TITANIUM DIOXIDE 3.67%
    ATRACTYLODES JAPONICA ROOT OIL 0.0525%
  • 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.

  • PRINCIPAL DISPLAY PANEL

    OHUI Sun luminous Whitening Sun block

  • INGREDIENTS AND APPEARANCE
    OHUI SUNSCIENCE LUMINOUS WHITENING SUNBLOCK 
    ensulizole, octisalate, bemotrizinol, octocrylene, diethylamino hydroxybenzoyl hexyl benzoate, zinc oxide, titanium dioxide, atractylodes japonica root oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-518
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.9 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.7 mL  in 100 mL
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mL  in 100 mL
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE1 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.3 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.67 mL  in 100 mL
    ATRACTYLODES JAPONICA ROOT OIL (UNII: EC228KGY00) (ATRACTYLODES JAPONICA ROOT OIL - UNII:EC228KGY00) ATRACTYLODES JAPONICA ROOT OIL0.525 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HECTORITE (UNII: 08X4KI73EZ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-518-021 in 1 BOX
    1NDC:53208-518-0150 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/06/2011
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture