LASTING FOUNDATION SPF 12 MERLE NORMAN- titanium dioxide cream 
Merle Norman

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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active ingredients                       Purpose

TITANIUM DIOXIDE 8%              Sunscreen     

Uses
· helps prevent sunburn

· Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

· Stop use and ask a doctor if rash occurs and persists


WARNINGS

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

 For external use only
 Do not use on damaged or broken skin
 When using this product keep out of eyes. Rinse with water to remove.

Directions
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months of age: Ask a doctor

ISODODECANE,ISOHEXADECANE, ZINC OXIDE (CI 77947), IRON OXIDES ,BUTYLENE/ETHYLENE/PROPYLENE COPOLYMER , SILICA ,DISTEARDIMONIUM HECTORITE, POLYMETHYL METHACRYLATE,TALC,POLYGLYCERYL - 3 DIISOSTEARATE ,
POLYETHYLENE, RETINYL PALMITATE, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE , TRI ETHOXYCAPRYLYLSILANE , PROPYLENE CARBONATE, ETHYLEN E B RASSYLATE, BENZYL ALCOHOL 071609.






image of primary label

Lasting Foundation
SPF 12
Fond De Teint
Durable FPS 12

Merle Norman

30 mL  1 FL. OZ.
NPN80019428





image of secondary label

LASTING FOUNDATION SPF 12  MERLE NORMAN
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.4 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
ISODODECANE 
ISOHEXADECANE 
ZINC OXIDE 
FERROUS OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
TALC 
VITAMIN A PALMITATE 
TETRAHEXYLDECYL ASCORBATE 
PROPYLENE CARBONATE 
ETHYLENE BRASSYLATE 
BENZYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:57627-110-021 in 1 BOX
1NDC:57627-110-0130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/22/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman008479388manufacture(57627-110)

Revised: 07/2012
Document Id: 357b159e-b586-4d64-b270-04a6c7da84c6
Set id: d31cfc74-7dcf-4af1-ba53-63fcad414464
Version: 8
Effective Time: 20120723
 
Merle Norman