Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:06:05

Label at a glance#

ProductLancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishin...
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: ● shake well ● apply generously and evenly 15minutes 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 mea...

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 10%

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:

● shake well

● apply generously and evenly 15minutes 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, glycerin, alcohol denat., glyceryl stearate, theobroma cacao (cocoa) seed butter, squalane, silica, PEG-100 stearate, glycol distearate, oryza sativa (rice) bran oil, butylene glycol, tocopheryl acetate, lactic acid, vaccinium myrtillus fruit extract, saccharum officinarum (sugar cane) extact, padina pavonica extract, stearic acid, pehnoxyethanol, acer saccharum (sugar maple) extract, palmitic acid, chlorphenesin, polysorbate 80, chlorhexidine digluconate, dimethicone, ammonium polyacryloyldimethyl taurate, dimethiconol, limonene, xanthan gum, linalool, ginkgo biloba leaf extract, dioscorea villosa (wild yam) root extract, propylene glycol, isohexadecane, iron oxides, paraffin, acrylamide/sodium acryloyldimethyltaurate copolymer, rosa centifolia flower extract, tetrasodium EDTA, citrus aurantium dulcis (orange) fruit water, citrus limon (lemon) fruit extract, citronellol, citral, hexyldecanol, glycine soja (soybean) protein, glycyrrhiza glabra (licorice) root extrract, fragrance, sodium benzoate

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-137-01Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment1 in 1 CARTONLOTION19
49967-137-01Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment100 g in 1 BOTTLELOTION1009
49967-137-02Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment30 g in 1 BOTTLELOTION309
49967-137-02Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment1 in 1 CARTONLOTION19
49967-137-03Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment1 in 1 CARTONLOTION19
49967-137-03Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment100 g in 1 TUBELOTION1009
49967-137-04Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment1 in 1 CARTONLOTION19
49967-137-04Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment30 g in 1 TUBELOTION309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-137LANCOME PARIS ABSOLUE HAND PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE ANTI AGE SPOT UNIFYING AND REPLENISHING TREATMENT (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]9Current NDC, Legacy NDC, 8 package rows20231231_30cb2f12-1ebe-4850-be16-17748f0ba670.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-13749967-137-01, 49967-137-02, 49967-137-03, 49967-137-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing TreatmentAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc30cb2f12-1ebe-4850-be16-17748f0ba6702023-12-30WarningsExact identifier
ndc (package): 49967-137-03
ndc (package): 49967-137-02
ndc (package): 49967-137-01
ndc (package): 49967-137-04
ndc (product): 49967-137
ndc11 (package): 49967013702
ndc11 (package): 49967013704
ndc11 (package): 49967013703
ndc11 (package): 49967013701
spl id: 2d5e9c53-a423-4502-a461-0fce452b5828
spl set id: 30cb2f12-1ebe-4850-be16-17748f0ba670

Reported adverse events (FAERS/openFDA)#

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