LANCOME PARIS ABSOLUE BX MAKEUP BROAD SPECTRUM SPF 18 SUNSCREEN ABSOLUTE REPLENISHING RADIANT MAKEUP NORMAL TO DRY SKIN- octinoxate liquid

Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin by

Drug Labeling and Warnings

Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Beauty Manufacturing Solutions Corp., L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 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

Caution

Flammabile until dry. Avoid fire, flame and heat during application.

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 liberally 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, isohexadecane, dipentaerythrityl hexacaprylate/hexacaprate, isodecyl neopentanoate, glycerin, alcohol denat., PEG-30 dipolyhydroxystearate, methyl methacrylate crosspolymer, dicaprylyl carbonate, propanediol, paraffin, glycyrrhiza glabra (licorice) root extract, padina pavonica extract, aluminum hydroxide, adenosine, magnesium sulfate, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, propylene glycol, hydroxypropyl tetrahydropyrantriol, caprylyl glycol, dioscorea villosa (wild yam) root extract, disteardimonium hectorite, hexyldecanol, tocopheryl acetate, phenoxyethanol, linalool, limonene, citronellol, fragrance; may conain: titanium dioxide, iron oxides

Questions or comments?

1-800-LANCOME

(1-800-526-2663)

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(9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS ABSOLUE BX MAKEUP BROAD SPECTRUM SPF 18 SUNSCREEN ABSOLUTE REPLENISHING RADIANT MAKEUP NORMAL TO DRY SKIN 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPANEDIOL (UNII: 5965N8W85T)
PARAFFIN (UNII: I9O0E3H2ZE)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PADINA PAVONICA (UNII: 177U06NHZI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ADENOSINE (UNII: K72T3FS567)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HEXYLDECANOL (UNII: 151Z7P1317)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-439-01	1 in 1 CARTON	01/01/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-439-02	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(49967-439)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-439)