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

Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut by

Drug Labeling and Warnings

Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

Package Labeling:

INGREDIENTS AND APPEARANCE

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN WALNUT 
meradimate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-7600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	35 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-7600-1	1 in 1 CARTON	01/05/2017
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/05/2017

Labeler - Gurwitch Products, LLC (884875246)