SOORYEHAN JADAN SUN MILD  - octocrylene, zinc oxide, octinoxate, titanium dioxide 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  5.612mL/100mL

OCTINOXATE  7mL/100mL

OCTOCRYLENE  2mL/100mL

TITANIUM DIOXIDE  2mL/100mL

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.

Sooryehan

Sun Mild

SPF 45/PA++

mildcream

SOORYEHAN JADAN SUN MILD  
octocrylene, zinc oxide, octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-446
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.612 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2   in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ETHYLPARABEN (UNII: 14255EXE39)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-446-021 in 1 BOX
1NDC:53208-446-01100 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35805/20/2010
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: 5/2010
Document Id: 21977c7e-dbed-4069-aee8-8ef54f827924
Set id: 7688ddc9-dc07-4deb-a3b7-473d4304dfe5
Version: 3
Effective Time: 20100520
 
LG Household and Healthcare, Inc.