LAURA MERCIER FLAWLESS SKIN REPAIR OIL FREE DAY BROAD SPECTRUM SPF 15- avobenzone, octinoxate, oxybenzone lotion 
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 Oil Free Day Lotion Broad Spectrum SPF 15 Sunscreen

Drug Facts

Active ingredients

Avobenzone (0.80%)

Octinoxate (3.50%)

Oxybenzone (0.50%)

Purpose

Sunscreen

Uses

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:

Outer LabelInner Label

LAURA MERCIER FLAWLESS SKIN REPAIR OIL FREE DAY BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-0150
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-0150-11 in 1 CARTON04/13/2016
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 finalpart35204/13/2016
Labeler - Gurwitch Products, LLC (884875246)

Revised: 4/2016
Document Id: 3063406e-296b-0fe6-e054-00144ff8d46c
Set id: 9c0aab54-4abf-4c26-b0bb-184e2c87d4da
Version: 2
Effective Time: 20160413
 
Gurwitch Products, LLC