LAURA MERCIER FLAWLESS SKIN REPAIR DAY BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octinoxate, oxybenzone cream

Laura Mercier Flawless Skin Repair Day Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Laura Mercier Flawless Skin Repair Day Broad Spectrum SPF 15 Sunscreen 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

Avobenzone (0.80%) 
Octinoxate (3.50%) 
Oxybenzone (0.50%)

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, Sea Water, Glycerin, Polymethylsilsesquioxane, Trehalose, Dimethicone, Squalane, Butylene Glycol, Polyglyceryl-10 Isostearate, Dicaprylyl Carbonate, Cetearyl Alcohol, Beeswax, Vitis Vinifera (Grape) Seed Oil, Hydrolyzed Xylan, Argania Spinosa Kernel Oil, Camellia Sinensis Leaf powder, Phenoxyethanol, Polyacrylamide, Carbomer, C13-14 Isoparaf n, Tocopheryl Acetate, PVM/MA Decadiene Crosspolymer, Disodium EDTA, Potassium Hydroxide, Pyrus Cydonia Seed Extract, Laureth-7, Glycosphingolipids, Glycerylamidoethyl Methacrylate/Stearyl Methacrylate Copolymer, Sodium Polyacrylate, Synthetic Fluorphlogopite, Aluminum Hydroxide, Hydrolyzed Collagen, Ethyl Oleate, Dipotassium Glycyrrhizate, Caprylic/Capric Triglyceride, Zinc Oxide, Tocopherol, Yeast Extract, Yeast Beta-Glucan, Sodium Ascorbyl Phosphate, Hydrogen Dimethicone, Oligopeptide-6, Tripeptide-3, Hexapeptide-3, Linalool.

Questions or comments?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

LAURA MERCIER FLAWLESS SKIN REPAIR DAY BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-7500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	8 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
YELLOW WAX (UNII: 2ZA36H0S2V)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ARGAN OIL (UNII: 4V59G5UW9X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
LAURETH-7 (UNII: Z95S6G8201)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ETHYL OLEATE (UNII: Z2Z439864Y)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ZINC OXIDE (UNII: SOI2LOH54Z)
TOCOPHEROL (UNII: R0ZB2556P8)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-7500-1	1 in 1 CARTON	01/05/2017
1		50 mL in 1 JAR; 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)