OHUI SUN SCIENCE PERFECT SUNBLOCK BLACK EX PLUS (ZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE ) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]

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  • OHUI SUN SCIENCE PERFECT SUNBLOCK BLACK EX PLUS (ZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE ) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]

OHUI SUN SCIENCE PERFECT SUNBLOCK BLACK EX PLUS (ZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE ) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-538-01, 53208-538-02
Set ID 3b37d822-e7b4-48df-b3f8-78030c20a175
Category HUMAN OTC DRUG LABEL
Packager LG Household and Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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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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