Label: OHUI SUN SCIENCE PERFECT SUNBLOCK BLACK EX PLUS- zinc oxide, titanium dioxide, ensulizole 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 August 3, 2011

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  • ACTIVE INGREDIENT

    ZINC OXIDE 22.7%

    TITANIUM DIOXIDE 10%

    ENSULIZOLE 3.9%

  • WARNINGS AND PRECAUTIONS

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • PRINCIPAL DISPLAY PANEL

    OHUI SUN SCIENCE Perfect Sunblock black EX plus

    Sun Perfect Black

  • INGREDIENTS AND APPEARANCE
    OHUI SUN SCIENCE PERFECT SUNBLOCK BLACK EX PLUS 
    zinc oxide, titanium dioxide, ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-538
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.7 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 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)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    VANILLA (UNII: Q74T35078H)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-538-021 in 1 BOX
    1NDC:53208-538-0160 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/03/2011
    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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