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

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OHUI SUN SCIENCE PERFECT SUNBLOCK RED EX (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-494-01, 53208-494-02
Set ID 9bd755cf-5744-48fe-be61-3b2b16b5d3e5
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 13.34%

    TITANIUM DIOXIDE 7%

  • 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 Perfect Red EX

    Ohui Sun Perfect Red EX

  • INGREDIENTS AND APPEARANCE
    OHUI SUN SCIENCE PERFECT SUNBLOCK RED EX 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-494
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.34 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    VANILLA (UNII: Q74T35078H)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FRUIT (UNII: C2AIY4ERZC)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    HECTORITE (UNII: 08X4KI73EZ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    SORBITAN (UNII: 6O92ICV9RU)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ENSULIZOLE (UNII: 9YQ9DI1W42)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    TALC (UNII: 7SEV7J4R1U)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MICA (UNII: V8A1AW0880)  
    CHROMIUM (UNII: 0R0008Q3JB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-494-021 in 1 BOX
    1NDC:53208-494-0160 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/16/2010
    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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