ISA KNOX TIMELESS ESSENCE SKIN COVER 21  - octinoxate and 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.

----------

OCTINOXATE  3.00g/100g

TITANIUM DIOXIDE  22.00g/100g

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.

TimelessEssenceSkinCover21


ISA KNOX TIMELESS ESSENCE SKIN COVER 21 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE22.00 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CANDELILLA WAX 
2-ETHYLHEXANOIC ACID 
DIMETHICONE 
SORBITAN MONOSTEARATE 
ADIPIC ACID 
ALUMINUM OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
CYCLOMETHICONE 5 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:53208-400-021 CONTAINER ( CONTAINER) in 1 BOXcontains a CONTAINER (53208-400-01)
1NDC:53208-400-0114 g in 1 CONTAINERThis package is contained within the BOX (53208-400-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/30/201006/01/2011

Labeler - LG Household and Healthcare, Inc. (688276187)
Registrant - LG Household and Healthcare, Inc. (688276187)
Establishment
NameAddressID/FEIOperations
LG Household and Healthcare, Inc.688276187manufacture

Revised: 03/2012 LG Household and Healthcare, Inc.