FDA.reportPublic FDA data

Lancome Paris Absolue Premium Bx Absolute Replenishing SPF 15

Manufacturer
L'Oreal USA Products Inc
Effective date
2018-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:12:18

Label at a glance#

ProductLancome Paris Absolue Premium Bx Absolute Replenishing SPF 15
Active ingredientAvobenzone, Octisalate, Octocrylene
Label structure10 sections

Indications and uses

sunscreen

Dosage and administration

Apply daily on cleansed skin before sun exposure.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%, Octisalate 5%, Octocrylene 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Directions

DOSAGE & ADMINISTRATION SECTION

Apply daily on cleansed skin before sun exposure.

Uses

INDICATIONS & USAGE SECTION

  • sunscreen

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

NOT TO BE SWALLOWED.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX3
OctisalateACTIVE INGREDIENT4X49Y0596W3
OctocryleneACTIVE INGREDIENT5A68WGF6WM3
AvobenzoneACTIVE MOIETYG63QQF2NOX3
OctisalateACTIVE MOIETY4X49Y0596W3
OctocryleneACTIVE MOIETY5A68WGF6WM3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-19549967-195-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
WATER059QF0KO0RIACT
BIS-PEG-18 METHYL ETHER DIMETHYL SILANEOEB4R3WW9CIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
PETROLATUM4T6H12BN9UIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
HYDROXYPROPYL TETRAHYDROPYRANTRIOL4U3GMG1OT1IACT
SODIUM HYDROXIDE55X04QC32IIACT
ADENOSINEK72T3FS567IACT
PEG-100 STEARATEYD01N1999RIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLOYL SALICYLIC ACID5F7PJF6AA4IACT
PARAFFINI9O0E3H2ZEIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL ALCOHOL936JST6JCNIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
OCTYLDODECANOL461N1O614YIACT
LAURETH-7Z95S6G8201IACT
HEXYLDECANOL151Z7P1317IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7daad13c-7f37-47e1-9b56-79a5d695f18ca4dc2ad1-a560-4cf3-97f9-0b0291ef5d182018-12-27WarningsExact identifier
spl id: 7daad13c-7f37-47e1-9b56-79a5d695f18c
spl set id: a4dc2ad1-a560-4cf3-97f9-0b0291ef5d18

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.