Laura Mercier Tinted Moisturizer SPF-20 Tan: Package Insert and Label Information

LAURA MERCIER TINTED MOISTURIZER SPF-20 TAN — octinoxate and meradimate cream
Gurwitch Products, L.L.C.

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 (7.5%) , Meradimate (3.5%)

WARNINGS : AFOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF SIGNS OF RASH OR IRRITATION APPEAR.

Keep out of reach of children.

Direction for use : Apply to cleansed skin with fingertips. Layer fro additional coverage.

Ingredients : Purified Water , Cetearyl Alcohol (And) PEG-40 Castor Oil (And) POE-20 , Dimethicone ,Polyglyceryl-4 Isostearate ,Cyclomethicone , DEA-Ceryl Phospate, Hexyl Laurate ,Kalaya Oil , Tocopheryl Acetate ,Cetyl Dimethicone Copolyol , Diazolidinyl Urea, Sodium Dehydroacetate ,Sodium Hyaluronate , Allantoin ,Carbomer Methylparaben, Magensium Aluminum Silicate , Sodium Ascorbate, Propylparaben, (+/-) Titanium Dioxide , Iron Oixde , Mica

LAURA MERCIER TINTED MOISTURIZER SPF-20 TAN octinoxate ,meradimate cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65342-1380 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 3 mg in 40 mg MERADIMATE (MERADIMATE) MERADIMATE 1.4 mg in 40 mg

Inactive Ingredients Ingredient Name Strength Water Dimethicone POLYGLYCERYL-4 ISOSTEARATE CETOSTEARYL ALCOHOL POLYOXYL 40 CASTOR OIL HEXYL LAURATE .ALPHA.-TOCOPHEROL ACETATE, D- SODIUM DEHYDROACETATE HYALURONATE SODIUM ALLANTOIN METHYLPARABEN MAGNESIUM ALUMINUM SILICATE SODIUM ASCORBATE PROPYLPARABEN TITANIUM DIOXIDE DIAZOLIDINYL UREA FERRIC OXIDE RED MICA

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65342-1380-0 40 mg in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/13/2005

Labeler — Gurwitch Products, L.L.C. (884875246)

Registrant — Beautymanuracuting Solutions Corperation (783200723)

Establishment
Name	Address	ID/FEI	Operations
Beautymanuracuting Solutions Corperation		783200723	manufacture

Revised: 05/2011 Gurwitch Products, L.L.C.