Label: OHUI SUN SCIENCE INTENSIVE SUNBLOCK CAKE EX- zinc oxide, octinoxate, titanium dioxide, bemotrizinol 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 July 16, 2010

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  • ACTIVE INGREDIENT

    ZINC OXIDE 10.528g/100g

    OCTINOXATE 7g/100g

    TITANIUM DIOXIDE 4g/100g

    BEMOTRIZINOL 1.5g/100g

  • 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

    Intensive Sunblock Cake EX

    OH SUNBLOCK EX


  • INGREDIENTS AND APPEARANCE
    OHUI SUN SCIENCE INTENSIVE SUNBLOCK CAKE EX 
    zinc oxide, octinoxate, titanium dioxide, bemotrizinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-473
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.528 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 g
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL 1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-473-022 in 1 BOX
    1NDC:53208-473-0115 g 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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