Label: ISA KNOX SMART BB SUN- octinoxate, titanium dioxide, zinc oxide, hydroxyproline, atractylodes japonica root oil cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 12, 2011

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  • ACTIVE INGREDIENT

    OCTINOXATE 7%

    TITANIUM DIOXIDE 6.72%

    ZINC OXIDE 2.88%

    HYDROXYPROLINE 0.5 %

    ATRACTYLODES JAPONICA ROOT OIL 0.05%


  • WARNINGS AND PRECAUTIONS

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • PRINCIPAL DISPLAY PANEL

    IK Smart Sun BB

  • INGREDIENTS AND APPEARANCE
    ISA KNOX SMART BB SUN 
    octinoxate, titanium dioxide, zinc oxide, hydroxyproline, atractylodes japonica root oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.72 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.88 mL  in 100 mL
    HYDROXYPROLINE (UNII: RMB44WO89X) (HYDROXYPROLINE - UNII:RMB44WO89X) HYDROXYPROLINE0.5 mL  in 100 mL
    ATRACTYLODES JAPONICA ROOT OIL (UNII: EC228KGY00) (ATRACTYLODES JAPONICA ROOT OIL - UNII:EC228KGY00) ATRACTYLODES JAPONICA ROOT OIL0.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ENSULIZOLE (UNII: 9YQ9DI1W42)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HECTORITE (UNII: 08X4KI73EZ)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    IRON (UNII: E1UOL152H7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ACETATE ION (UNII: 569DQM74SC)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CANNA INDICA ROOT (UNII: BZK836AQFQ)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-520-021 in 1 BOX
    1NDC:53208-520-0160 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/12/2011
    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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