Drug Facts

Manufacturer
L'Oreal USA Products Inc | Beauty Manufacturing Solutions Corp. | L'Oreal USA, Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:06:07

Label at a glance#

ProductLancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin
Active ingredientOCTINOXATE
Label structure14 sections

Indications and 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

Dosage and administration

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 incl...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Caution

USER SAFETY WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-LANCOME

(1-800-526-2663)

Monday - Friday

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-439-01Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin1 in 1 CARTONLIQUID17
49967-439-01Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin30 mL in 1 BOTTLELIQUID307
49967-439-02Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin10 mL in 1 BOTTLELIQUID107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-439LANCOME PARIS ABSOLUE BX MAKEUP BROAD SPECTRUM SPF 18 SUNSCREEN ABSOLUTE REPLENISHING RADIANT MAKEUP NORMAL TO DRY SKIN (OCTINOXATE) LIQUID [L'OREAL USA PRODUCTS INC]7Current NDC, Legacy NDC, 3 package rows20231231_a45fef28-5dde-48b2-b7c0-ede694f4c32b.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-43949967-439-01, 49967-439-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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
Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry SkinOCTINOXATEL'Oreal USA Products Inca45fef28-5dde-48b2-b7c0-ede694f4c32b2023-12-30WarningsExact identifier
ndc (package): 49967-439-02
ndc (package): 49967-439-01
ndc (product): 49967-439
ndc11 (package): 49967043902
ndc11 (package): 49967043901
spl id: 9f7072f1-83aa-4eb2-9e93-7566b056e83b
spl set id: a45fef28-5dde-48b2-b7c0-ede694f4c32b

Reported adverse events (FAERS/openFDA)#

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