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

Laura mercier Tinted Moisturizer SPF-20 Tan by

Drug Labeling and Warnings

Laura mercier Tinted Moisturizer SPF-20 Tan by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, L.L.C., Beautymanuracuting Solutions Corperation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate (7.5%) , Meradimate (3.5%)

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3 mg  in 40 mg
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	1.4 mg  in 40 mg

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-1380-0	40 mg in 1 TUBE

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	Business Operations
Beautymanuracuting Solutions Corperation		783200723	manufacture