LOREAL PARIS REVITALIFT ANTIWRINKLE PLUS FIRMING SPF 18 SUNSCREEN DAY MOISTURIZER- ensulizole and octinoxate cream

LOreal Paris Revitalift Antiwrinkle Plus Firming SPF 18 Sunscreen Day Moisturizer by

Drug Labeling and Warnings

LOreal Paris Revitalift Antiwrinkle Plus Firming SPF 18 Sunscreen Day Moisturizer 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%

Octinoxate 7.5%

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, cyclohexasiloxane, glycerin, myristyl myristate, alcohol denat., triethanolamine, stearic acid, ammonium polyacryloyldimethyl taurate, palmitic acid, titanium dioxide, PEG-100 stearate, glyceryl stearate, beeswax, PEG-20 stearate, stearyl alcohol, glycine soja (soybean) protein, alumina, phenethyl alcohol, hydrolyzed soy protein, yeast extract, acetyl trifluoromethylphenyl valylglycine, acrylates, copolymer, cetyl alcohol, retinyl palmitate, postassium sorbate, methylparaben, sodium benzoate, phenoxyethanol, chlorphenesin, ethylparaben, linalool, geraniol, alpha-isomethyl ionone, amyl cinnamal, limonene, citral, citronellol, butylphenyl methylpropional, hexyl cinnamal, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS REVITALIFT ANTIWRINKLE PLUS FIRMING SPF 18 SUNSCREEN DAY MOISTURIZER 
ensulizole and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-458
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 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-458-01	1 in 1 CARTON	01/01/2015
1		48 g in 1 JAR; 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	01/01/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(49967-458)