LOREAL PARIS SKIN EXPERTISE DAY MOISTURIZER FUTUR E DAILY DOSE OF PURE VITAMIN E NORMAL TO DRY SKIN SPF 15- ensulizole and octocrylene lotion

Loreal Paris Skin Expertise Day Moisturizer Futur E Daily Dose of Pure Vitamin E Normal to Dry Skin SPF 15 by

Drug Labeling and Warnings

Loreal Paris Skin Expertise Day Moisturizer Futur E Daily Dose of Pure Vitamin E Normal to Dry Skin SPF 15 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Ensulizole 2%

Octocrylene 7%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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, glycerin, cyclopentasiloxane, aluminum starch octenylsuccinate, octyldodecanol, ammonium polyacryloyldimethyl taurate, triethanolamine, hydrogenated lecithin, tocopheryl acetate, disodium phosphate, cholesterol, panthenol, capryloyl salicylic acid, sodium stearoyl glutamate, sodium phosphate, glycine soja (soybean) oil, tocopherol, polycaprolactone, disodium EDTA, methylparaben, diazolidinyl urea, propylparaben, phenoxyethanol, fragrance, benzyl salicylate, butylphenyl methylpropional, hydroxyisohexyl 3-cyclohexene carboxaldehyde, alpha-isomethyl ionone, linalool, hexyl cinnamal, citronellol, geraniol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS SKIN EXPERTISE DAY MOISTURIZER FUTUR E DAILY DOSE OF PURE VITAMIN E NORMAL TO DRY SKIN SPF 15 
ensulizole and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-294
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
OCTYLDODECANOL (UNII: 461N1O614Y)
TROLAMINE (UNII: 9O3K93S3TK)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PANTHENOL (UNII: WV9CM0O67Z)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-294-01	1 in 1 CARTON	06/01/2012
1		118 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	06/01/2012

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		624244349	manufacture(49967-294) , pack(49967-294)