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

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

Drug Labeling and Warnings

Laura Mercier Flawless Skin Repair Oil Free Day Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by JO Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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, 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/Label Principal Display Panel

laura mercier

flawless skin

REPAIR OIL-FREE
DAY LOTION
BROAD SPECTRUM
SPF 15 SUNSCREEN

50 mL/1.7 FL. OZ. LIQ.

Carton Label

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24463-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.8 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 100 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)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
SQUALANE (UNII: GW89575KF9)
TREHALOSE (UNII: B8WCK70T7I)
ETHYL OLEATE (UNII: Z2Z439864Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ARGININE (UNII: 94ZLA3W45F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.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)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24463-015-01	1 in 1 BOX	01/01/2016
1		50 mL in 1 BOTTLE; 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	01/01/2016

Labeler - JO Cosmetics Co., Ltd. (692780372)

Registrant - JO Cosmetics Co., Ltd. (691485222)

Establishment
Name	Address	ID/FEI	Business Operations
JO Cosmetics Co., Ltd.		691485222	MANUFACTURE(24463-015) , ANALYSIS(24463-015)