OH AGE RECOVERY TRI SHIELD PACT 10 - titanium dioxide, octinoxate powder 
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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OHUI AGE RECOVERY TRI SHIELD PACT NO10

TITANIUM DIOXIDE          4.9%
OCTINOXATE                  2%


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.

Tri Shiled 10


OH AGE RECOVERY TRI SHIELD PACT 10 
titanium dioxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-551
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MICA (UNII: V8A1AW0880)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
LAUROYL LYSINE (UNII: 113171Q70B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
WATER (UNII: 059QF0KO0R)  
CERAMIDE 3 (UNII: 4370DF050B)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYDATIN (UNII: XM261C37CQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-551-021 in 1 BOX
1NDC:53208-551-0113 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/27/2011
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: 5/2012
Document Id: bffe4087-0880-49cd-959a-203af5015cc1
Set id: c020925c-3503-4044-b2dd-15f0f07588f1
Version: 5
Effective Time: 20120514
 
LG Household and Healthcare, Inc.