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

  • NDC Code(s): 53208-494-01, 53208-494-02
  • Packager: LG Household and Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/10

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

  • ACTIVE INGREDIENT

    ZINC OXIDE 13.34%

    TITANIUM DIOXIDE 7%

    Close
  • WARNINGS AND PRECAUTIONS

    For external use only.

    Close
  • Keep out of reach of children

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

    Close
  • STOP USE

    Stop use if a rash or irritation develops and lasts.

    Close
  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

    Close
  • PRINCIPAL DISPLAY PANEL

    Ohui Sun Perfect Red EX

    Ohui Sun Perfect Red EX

    Close
  • INGREDIENTS AND APPEARANCE
    OHUI SUN SCIENCE PERFECT SUNBLOCK RED EX 
    zinc oxide, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-494
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.34 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53208-494-02 1 in 1 BOX
    1 NDC:53208-494-01 60 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/16/2010
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    Name Address ID/FEI Business Operations
    LG Household and Healthcare, Inc. 688276187 manufacture
    Close