LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN WALNUT- meradimate, octinoxate cream 
Gurwitch Products, LLC

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 Walnut

Drug Facts

Active ingredients

Meradimate 3.5%
Octinoxate 7.5% 

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

• For sunscreen use:
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours 
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m. 
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun.

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 dimethcone, polysorbate 60, diazolidinyl urea, sodium dehydroacetate, sodium hyaluronate, allantoin, carbomer, methylparaben, 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.

Package Labeling:

outer Label2Inner Label2

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN WALNUT 
meradimate, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-7600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE35 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
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)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALLANTOIN (UNII: 344S277G0Z)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SODIUM ASCORBATE (UNII: S033EH8359)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-7600-11 in 1 CARTON01/05/2017
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/05/2017
Labeler - Gurwitch Products, LLC (884875246)

Revised: 1/2017
Document Id: 457119e5-1f79-3462-e054-00144ff88e88
Set id: 457119e5-1f78-3462-e054-00144ff88e88
Version: 1
Effective Time: 20170106
 
Gurwitch Products, LLC