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

  • Label RSS
  • 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%

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  • WARNINGS AND PRECAUTIONS

    For external use only.

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  • Keep out of reach of children

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

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  • STOP USE

    Stop use if a rash or irritation develops and lasts.

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  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

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  • PRINCIPAL DISPLAY PANEL

    Ohui Sun Perfect Red EX

    Ohui Sun Perfect Red EX

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  • INGREDIENTS AND APPEARANCE
    OHUI SUN SCIENCE PERFECT SUNBLOCK RED EX 
    zinc oxide, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53208-494
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 13.34 mL  in 100 mL
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 7 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONE  
    WATER  
    CYCLOMETHICONE 5  
    METHYLPARABEN  
    BUTYLENE GLYCOL  
    VANILLA  
    CETYL ETHYLHEXANOATE  
    GLYCERIN  
    DIPROPYLENE GLYCOL  
    HEXYL LAURATE  
    FRUIT  
    MAGNESIUM SULFATE, UNSPECIFIED  
    HECTORITE  
    ALUMINUM OXIDE  
    ZINC STEARATE  
    SORBITAN  
    PANTHENOL  
    ISOSTEARIC ACID  
    ENSULIZOLE  
    TROLAMINE  
    DISTEARYLDIMONIUM CHLORIDE  
    TALC  
    ETHYLPARABEN  
    MICA  
    CHROMIUM  
    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
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