LASTING FOUNDATION SPF 12 MERLE NORMAN- titanium dioxide cream

Lasting Foundation SPF 12 by

Drug Labeling and Warnings

Lasting Foundation SPF 12 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

For Sunscreen use
· 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

PRINCIPAL DISPLAY PANEL

Lasting Foundation
SPF 12
Fond De Teint
Durable FPS 12

Merle Norman

30 mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

LASTING FOUNDATION SPF 12  MERLE NORMAN
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.4 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
ZINC OXIDE (UNII: SOI2LOH54Z)
FERROUS OXIDE (UNII: G7036X8B5H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-110-02	1 in 1 BOX	04/22/2011
1	NDC: 57627-110-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/22/2011

Labeler - Merle Norman Cosmetics, Inc (008479388)

Registrant - Merle Norman Cosmetics, Inc (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc		008479388	manufacture(57627-110)