LANCOME PARIS BIENFAIT UV 50 PLUS BROAD SPECTRUM SPF 50 PLUS WATER RESISTANT 80 MINUTES SUPER FLUID FACIAL SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial Sunscreen by

Drug Labeling and Warnings

Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc., Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

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:

● shake well

● apply generously and evenly 15 minutes before sun exposure

● reapply:

● after 80 minutes of swimming or sweating

● immediately after towel drying

● 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, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, capryly glycol, methylparaben, poly C10-30 alkyl acrylate, disteardimonium hectorite, disodium EDTA, dodecene, poloxamer 407

Questions or comments?

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS BIENFAIT UV 50 PLUS BROAD SPECTRUM SPF 50 PLUS WATER RESISTANT 80 MINUTES SUPER FLUID FACIAL SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-754
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
NYLON-12 (UNII: 446U8J075B)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-754-01	1 in 1 CARTON	08/01/2010
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	08/01/2010

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-754)