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

Laura Mercier Flawless Skin Repair by

Drug Labeling and Warnings

Laura Mercier Flawless Skin Repair by is a Otc medication manufactured, distributed, or labeled by Laura Mercier. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone (0.80%)	Sunscreen
Octinoxate (3.50%)	Sunscreen
Oxybenzone (0.50%)	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, 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.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

laura mercier

flawless skin

REPAIR OIL-FREE
DAY LOTION
BROAD SPECTRUM
SPF 15 SUNSCREEN

50 mL/1.7 FL. OZ. LIQ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-366
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	400 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1750 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	250 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
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)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
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)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRICAPRILIN (UNII: 6P92858988)
ZINC OXIDE (UNII: SOI2LOH54Z)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-366-10	1 in 1 CARTON	04/13/2016
1		50 mL in 1 BOTTLE, PUMP; 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 - Laura Mercier (193691821)