Label: ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 21- titanium dioxide, octinoxate powder
ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 21 (REFILL)- titanium dioxide, octinoxate powder

  • 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 June 20, 2012

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

  • ACTIVE INGREDIENT

    TITANIUM DIOXIDE 13.38g/100g

    OCTINOXATE 4g/100g

  • 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.
  • PRINCIPAL DISPLAY PANEL

    Ageless Serun TWC21

  • INGREDIENTS AND APPEARANCE
    ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 21 
    titanium dioxide, octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.38 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MICA (UNII: V8A1AW0880)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BENZNIDAZOLE (UNII: YC42NRJ1ZD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-511-021 in 1 CARTON
    1NDC:53208-511-0111 g in 1 TRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/28/201103/28/2012
    ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 21 (REFILL) 
    titanium dioxide, octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-519
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.38 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MICA (UNII: V8A1AW0880)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BENZNIDAZOLE (UNII: YC42NRJ1ZD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-519-021 in 1 CARTON
    1NDC:53208-519-0111 g in 1 TRAY
    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