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

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 Cosmetics. 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, 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 Isoparaffin, 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.

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

laura mercier

flawless skin

REPAIR DAY CRÈME
BROAD SPECTRUM SPF 15 SUNSCREEN

50 g / NET WT. 1.7 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-412
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 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
YELLOW WAX (UNII: 2ZA36H0S2V)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ARGAN OIL (UNII: 4V59G5UW9X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
LAURETH-7 (UNII: Z95S6G8201)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ARGININE (UNII: 94ZLA3W45F)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ETHYL OLEATE (UNII: Z2Z439864Y)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ZINC OXIDE (UNII: SOI2LOH54Z)
TOCOPHEROL (UNII: R0ZB2556P8)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
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: 58411-412-60	1 in 1 CARTON	10/25/2016
1		50 g in 1 TUBE; 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	10/25/2016

Labeler - Laura Mercier Cosmetics (193691821)