LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN - NUDE- meradimate, octinoxate 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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Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Nude

Drug Facts

Active Ingredients

Meradimate (3.5%)

Octinoxate (7.5%)

Purpose

Sunscreen

Uses

Warnings:

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.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Other information:

Inactive ingredients

water, cetearyl alcohol, peg-40 castor oil, dimethicone, polyglyceryl-4 isostearate, cyclomethicone, dea-cetyl phosphate, hexyl laurate, emu oil, tocopheryl acetate, cetyl peg/ppg-10/1 dimethicone, polysorbate 60, diazolidinyl urea, magnesium aluminum silicate, sodium ascorbate, propylparaben. may contain:iron oxides, titanium dioxide, mica

Questions or comments?

Call 1-888-637-2437, M - F 9am - 5pm CST.

Product Label

Packet

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN - NUDE 
meradimate, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-1403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE35 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
EMU OIL (UNII: 344821WD61)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SODIUM ASCORBATE (UNII: S033EH8359)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-1403-02 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/09/2015
Labeler - Gurwitch Products, L.L.C. (884875246)
Establishment
NameAddressID/FEIBusiness Operations
Qualis Packaging078387992pack(65342-1403)

Revised: 7/2015
Document Id: 479fc953-749c-4d0e-8083-d74efe6e631a
Set id: 0f1c7822-691c-4d55-922a-cd88df5526de
Version: 1
Effective Time: 20150710
 
Gurwitch Products, L.L.C.