LANCOME PARIS ABSOLUE PREMIUM BX ABSOLUTE REPLENISHING SPF 15- avobenzone, octisalate and octocrylene cream

Lancome Paris Absolue Premium Bx Absolute Replenishing SPF 15 by

Drug Labeling and Warnings

Lancome Paris Absolue Premium Bx Absolute Replenishing SPF 15 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2%, Octisalate 5%, Octocrylene 8%

Purpose

Sunscreen

Directions

Apply daily on cleansed skin before sun exposure.

Uses

• sunscreen

Warnings

FOR EXTERNAL USE ONLY

When using this product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Stop use and ask a doctor if

SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. 

Keep out of reach of children.

NOT TO BE SWALLOWED.

Inactive ingredients

WATER ●
HYDROGENATED POLYISOBUTENE ●
ALCOHOL DENAT. ●
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE ●
GLYCERIN ●
CYCLOHEXASILOXANE ●
CETEARYL ALCOHOL ●
DIMETHICONE ●
PEG-20 ●
PRUNUS ARMENIACA (APRICOT) KERNEL OIL ●
PETROLATUM ●
C13-14 ISOPARAFFIN ●
TOCOPHERYL ACETATE ●
HYDROXYPROPYL TETRAHYDROPYRANTRIOL ●
HYDROLYZED MALT EXTRACT ●
SODIUM HYALURONATE ●
PADINA PAVONICA EXTRACT ●
SODIUM HYDROXIDE ●
HYDROLYZED SOY PROTEIN ●
ADENOSINE ●
PEG-100 STEARATE ●
POLYACRYLAMIDE ●
CALCIUM PANTOTHENATE ●
DIMETHYL ISOSORBIDE ●
DIMETHICONOL ●
LIMONENE ●
XANTHAN GUM ●
LINALOOL ●
DIOSCOREA VILLOSA (WILD YAM) ROOT EXTRACT ●
IRON OXIDES ●
CAPRYLYL GLYCOL ●
CAPRYLOYL SALICYLIC ACID ●
PARAFFIN ●
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER ●
DISODIUM EDTA ●
BUTYROSPERMUM PARKII (SHEA BUTTER) ●
BUTYLENE GLYCOL ●
CETYL ALCOHOL ●
CETEARYL GLUCOSIDE ●
OCTYLDODECANOL ●
CITRONELLOL ●
LAURETH-7 ●
HEXYLDECANOL ●
GLYCERYL STEARATE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS ABSOLUE PREMIUM BX ABSOLUTE REPLENISHING SPF 15 
avobenzone, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ADENOSINE (UNII: K72T3FS567)
PEG-100 STEARATE (UNII: YD01N1999R)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
PARAFFIN (UNII: I9O0E3H2ZE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
OCTYLDODECANOL (UNII: 461N1O614Y)
LAURETH-7 (UNII: Z95S6G8201)
HEXYLDECANOL (UNII: 151Z7P1317)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-195-01	1 in 1 CARTON	06/01/2010	05/05/2014
1		50 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	06/01/2010

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		185931458	manufacture(49967-195)