LAURA MERCIER TINTED MOISTURIZER SPF-20 SAND - octinoxate ,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.

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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




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LAURA MERCIER TINTED MOISTURIZER SPF-20 SAND 
octinoxate ,meradimate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-1378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3 mg  in 40 mg
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE1.4 mg  in 40 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-1378-040 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/13/2005
Labeler - Gurwitch Products, L.L.C. (884875246)
Registrant - Beautymanuracuting Solutions Corperation (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beautymanuracuting Solutions Corperation783200723manufacture

Revised: 5/2011
Document Id: 60d26e79-1bcd-4044-bb9b-a62009ed1285
Set id: e87efa4a-b9f0-4105-9810-d80932241956
Version: 1
Effective Time: 20110502
 
Gurwitch Products, L.L.C.