Label: OHUI SUN SCIENCE PERFECT SUNBLOCK RED EX- zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 December 16, 2010

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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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