Drug Facts

Manufacturer
SICOS ET CIE
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:36

Label at a glance#

ProductLancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 Day
Active ingredientAvobenzone, Octisalate, Octocrylene
Label structure13 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: ● 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 includ...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octisalate 5%

Octocrylene 8%

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

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:

● 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

STORAGE AND HANDLING SECTION

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

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, fragrance

Questions or comments?

OTC - QUESTIONS SECTION

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 am - 5 pm EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51150-953-01Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 Day1 in 1 CARTONCREAM11
51150-953-01Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 Day75 g in 1 JARCREAM751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51150-953LANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING REJUVENATING BROAD SPECTRUM SPF 15 DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [SICOS ET CIE]1Current NDC, 2 package rows20231224_a9b7e52c-8799-49ba-8b05-7559fe6668fe.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51150-95351150-953-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 DayAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEa9b7e52c-8799-49ba-8b05-7559fe6668fe2023-12-23WarningsExact identifier
ndc (package): 51150-953-01
ndc (product): 51150-953
ndc11 (package): 51150095301
spl id: c4fb4255-92a7-4008-82ee-92727e216e98
spl set id: a9b7e52c-8799-49ba-8b05-7559fe6668fe

Reported adverse events (FAERS/openFDA)#

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