LAURA MERCIER FLAWLESS SKIN REPAIR DAY BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octinoxate, oxybenzone 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 Flawless Skin Repair Day Creme Broad Spectrum SPF 15 Sunscreen

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:

Outer LabelInner Label

LAURA MERCIER FLAWLESS SKIN REPAIR DAY BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, octinoxate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-7500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE8 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE35 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-7500-11 in 1 CARTON01/05/2017
150 mL in 1 JAR; 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: 457119e5-1f4b-3462-e054-00144ff88e88
Set id: 457119e5-1f4a-3462-e054-00144ff88e88
Version: 1
Effective Time: 20170106
 
Gurwitch Products, LLC