OHUI SUN SCIENCE PERFECT SUNBLOCK BLACK EX PLUS - zinc oxide, titanium dioxide, ensulizole  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 22.7%

TITANIUM DIOXIDE 10%

ENSULIZOLE 3.9%

For external use only.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop use if a rash or irritation develops and lasts.

Keep out of eyes. Rinse with water to remove.

OHUI SUN SCIENCE Perfect Sunblock black EX plus

Sun Perfect Black

OHUI SUN SCIENCE PERFECT SUNBLOCK BLACK EX PLUS 
zinc oxide, titanium dioxide, ensulizole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-538
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.7 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mL  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.9 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PANTHENOL (UNII: WV9CM0O67Z)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
VANILLA (UNII: Q74T35078H)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ZINC STEARATE (UNII: H92E6QA4FV)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ETHYLPARABEN (UNII: 14255EXE39)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-538-021 in 1 BOX
1NDC:53208-538-0160 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/03/2011
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: 8/2011
Document Id: 493b4e2c-9c76-4ee0-a7c6-83406607b171
Set id: 3b37d822-e7b4-48df-b3f8-78030c20a175
Version: 1
Effective Time: 20110803
 
LG Household and Healthcare, Inc.