ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]

ISA KNOX SMART BB SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-520-01, 53208-520-02
Set ID 3b4ab30b-920a-4790-8f3b-8c744f2f6a57
Category HUMAN OTC DRUG LABEL
Packager LG Household and Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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