OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK - octinoxate, titanium dioxide, octisalate, ensulizole, bis-ethylhexyloxyphenol methoxyphenyl triazine 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 Fact

OCTINOXATE 7%

TITANIUM DIOXIDE 6%

OCTISALATE 4.8%

ENSULIZOLE 3.9%

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE 0.5%

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.

First Cell Revolution
OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK 
octinoxate, titanium dioxide, octisalate, ensulizole, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-515
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.8 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.9 g  in 100 g
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE0.5 g  in 100 g
HYDROXYPROLINE (UNII: RMB44WO89X) (HYDROXYPROLINE - UNII:RMB44WO89X) HYDROXYPROLINE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
ALCOHOL (UNII: 3K9958V90M)  
ISODODECANE (UNII: A8289P68Y2)  
PANTHENOL (UNII: WV9CM0O67Z)  
METHYL METHACRYLATE (UNII: 196OC77688)  
INULIN (UNII: JOS53KRJ01)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-515-021 in 1 BOX
1NDC:53208-515-0140 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/06/2011
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: 3/2011
Document Id: 2b38f356-c9a4-4ebc-9034-bc6de1f11edc
Set id: adef3aa6-3369-4da2-b7c4-37d80ccdad66
Version: 1
Effective Time: 20110328
 
LG Household and Healthcare, Inc.