LAURA MERCIER FLAWLESS SKIN REPAIR OIL FREE DAY BROAD SPECTRUM SPF 15- avobenzone, octinoxate, oxybenzone lotion

Laura Mercier Flawless Skin Repair Oil Free Day Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Laura Mercier Flawless Skin Repair Oil Free Day Broad Spectrum SPF 15 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 ever y 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, Dicaprylyl Carbonate, Dimethicone, Butylene Glycol, Polyglyceryl-10 Isostearate, Squalane, Trehalose, Ethyl Oleate, Camellia Sinensis Leaf Powder, Phenoxyethanol, Polyacrylamide, Beeswax, C13-14 Isoparaffin, Carbomer, Arginine, Disodium EDTA, Tocopheryl Acetate, Laureth-7, Pyrus Cydonia Seed Extract, Glycosphingolipids, Sodium Polyacrylate, Glycerylamidoethyl Methacrylate/Stearyl Methacrylate Copolymer, Synthetic Fluorphlogopite, Aluminum Hydroxide, Hydrolyzed Collagen, Caprylic/Capric Triglyceride, Zinc Oxide, Dipotassium Glycyrrhizate, Sodium Ascorbyl Phosphate, Yeast Beta-Glucan, Yeast Extract, Hydrogen Dimethicone, Oligopeptide-6, Hexapeptide-3, Tripeptide-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 OIL FREE DAY BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-0150
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)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SQUALANE (UNII: GW89575KF9)
TREHALOSE (UNII: B8WCK70T7I)
ETHYL OLEATE (UNII: Z2Z439864Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ARGININE (UNII: 94ZLA3W45F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURETH-7 (UNII: Z95S6G8201)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ZINC OXIDE (UNII: SOI2LOH54Z)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-0150-1	1 in 1 CARTON	04/13/2016
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	04/13/2016

Labeler - Gurwitch Products, LLC (884875246)