ISA KNOX 365 SUN - zinc oxide, titanium dioxide, octinoxate cream 
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 Facts

ZINC OXIDE 11.04%

OCTINOXATE 7.02%

TITANIUM DIOXIDE 4.03%

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.

Stop use if a rash or irritation develops and lasts.

Isaknox

365 Sun Cream

365 Sun Cream

ISA KNOX 365 SUN 
zinc oxide, titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.04 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.2 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.03 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
PANTHENOL (UNII: WV9CM0O67Z)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
ETHYLPARABEN (UNII: 14255EXE39)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
ACETATE ION (UNII: 569DQM74SC)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
ZINC STEARATE (UNII: H92E6QA4FV)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
FRUIT (UNII: C2AIY4ERZC)  
MARITIME PINE (UNII: 50JZ5Z98QY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-502-021 in 1 BOX
1NDC:53208-502-0170 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/30/2010
Labeler - LG Household and Healthcare, Inc. (688276187)
Registrant - LG Household and Healthcare, Inc. (688276187)
Establishment
NameAddressID/FEIBusiness Operations
LG Household and Healthcare, Inc.688276187manufacture

Revised: 3/2011
Document Id: 2bda68ca-7ba8-45b6-807f-e1d4d22f1f50
Set id: 3b33257d-1e24-460c-ae1b-43b7ff9fc666
Version: 2
Effective Time: 20110310
 
LG Household and Healthcare, Inc.