ISA KNOX 365 SUN

Dosage form: cream
Ingredients: ZINC OXIDE 11.04mL in 100mL, OCTINOXATE 7.2mL in 100mL, TITANIUM DIOXIDE 4.03mL in 100mL
Labeler: LG Household and Healthcare, Inc.
NDC Code: 53208-502

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 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


ISA KNOX 365 SUN 
zinc oxide, titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-502
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE11.04 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.2 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4.03 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ZINC OXIDE 
BUTYLENE GLYCOL 
CYCLOMETHICONE 5  
DIPROPYLENE GLYCOL 
DIMETHICONE 
MAGNESIUM SULFATE, UNSPECIFIED 
SORBITAN SESQUIOLEATE 
PANTHENOL 
METHYLPARABEN 
CHAMAEMELUM NOBILE FLOWER 
ETHYLPARABEN 
SACCHARIDE ISOMERATE 
ACETATE ION 
DISTEARYLDIMONIUM CHLORIDE 
ZINC STEARATE 
CETYL ETHYLHEXANOATE 
FRUIT 
MARITIME PINE 
Packaging
#Item CodePackage Description
1NDC:53208-502-021 CONTAINER (CONTAINER) 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/FEIOperations
LG Household and Healthcare, Inc.688276187manufacture

Revised: 03/2011
 
LG Household and Healthcare, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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