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

Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Nude by

Drug Labeling and Warnings

Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Nude by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, L.L.C., Qualis Packaging. 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), decrease 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 AM to 2 PM.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor.

Other information:

• protect this product 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 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-1403
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 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-1403-0	2 g in 1 PACKET; 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	07/09/2015

Labeler - Gurwitch Products, L.L.C. (884875246)

Establishment
Name	Address	ID/FEI	Business Operations
Qualis Packaging		078387992	pack(65342-1403)