LANCOME PARIS BIENFAIT MULTIVITAL BROAD SPECTRUM SPF 30 SUNSCREEN 24 HOUR MOISTURIZATION ANTIOXIDANT AND VITAMIN ENRICHED- avobenzone, octisalate and octocrylene lotion

Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen 24 Hour Moisturization Antioxidant and Vitamin Enriched by

Drug Labeling and Warnings

Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen 24 Hour Moisturization Antioxidant and Vitamin Enriched by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

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 generously and evenly 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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, isononyl isononanoate, glycerin, dimethicone, diisopropyl sebacate, aluminum starch octenylsuccinate, sucrose tristearate, polysorbate 61, ribes nigrum (black currant) seed oil, tocopheryl acetate, ascorbyl glucoside, sodium stearoyl glutamate, hydroxycitronellal, hydroxyisohexyl 3-cyclohexene carboxaldehyde, phenoxyethanol, thermus thermophillus ferment, PEG-12 dimethicone, eugenol, ethylparaben, triethanolamine,helianthus annuus (sunfolower) seed oil, dimethiconol, panthenol, xanthan gum, benzyl salicylate, benzyl alcohol, linalool, oxothiazolidinecarboxylic acid, caprylyl glycol, alpha-isomethyl ionone, carbomer, geraniol, moringa pterygosperma seed exteract, disodium EDTA, castanea satia (chestnut) seed extract, rosa canina fruit oil, methylparaben, citonellol, hexyl cinnamal, fragrance

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 MULTIVITAL BROAD SPECTRUM SPF 30 SUNSCREEN 24 HOUR MOISTURIZATION ANTIOXIDANT AND VITAMIN ENRICHED 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-184
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
POLYSORBATE 61 (UNII: X9E1MY2JQG)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
EUGENOL (UNII: 3T8H1794QW)
ETHYLPARABEN (UNII: 14255EXE39)
TROLAMINE (UNII: 9O3K93S3TK)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PANTHENOL (UNII: WV9CM0O67Z)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
OXOTHIAZOLIDINECARBOXYLIC ACID (UNII: X7063P804E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
MORINGA OLEIFERA SEED (UNII: TIX5482832)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-184-01	1 in 1 CARTON	10/01/2005
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	10/01/2005

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-184)