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 
LG Household and Healthcare, Inc.

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.

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Drug Fact

TITANIUM DIOXIDE 13.38g/100g

OCTINOXATE 4g/100g

For external use only.

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

Keep out of eyes. Rinse with water to remove.

Ageless Serun TWC21

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

Revised: 6/2012
Document Id: 2001a873-4b20-40b8-9227-38ae7e483bd8
Set id: 79059f76-ef64-437b-87d6-76ea295bfff6
Version: 4
Effective Time: 20120620
 
LG Household and Healthcare, Inc.