FDA.reportPublic FDA data

L'BEL LEDERM 55 + JOUR Facial lotion against advanced signs of aging

Manufacturer
Bel Star S.A. (Colombia)
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:17:42

Label at a glance#

ProductLBEL LEDERM 55 plus JOUR Facial against advanced signs of aging
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone 3%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 3%Sunscreen
Oxybenzone 5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

Skin Cancer / Skin Aging Alert

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, notskin cancer or early skin aging.

SPL UNCLASSIFIED SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin.

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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, c12-15 alkyl benzoate, dimethicone, dicaprylyl carbonate, phenethyl benzoate, cyclopentasiloxane, potassium cetyl phosphate, cetearyl alcohol, cyclohexasiloxane, pentylene glycol, trilaureth-4 phosphate, caprylic/capric triglyceride, hydrogenated palm glycerides, methyl methacrylate crosspolymer, phenoxyethanol, cetyl alcohol, glyceryl stearate, albizia julibrissin bark extract, bis-vinyl dimethicone/dimethicone copolymer, peg-75 stearate, xanthan gum, ceteareth-20, chlorphenesin, fragrance, acrylates/c10-30 alkyl acrylate crosspolymer, ceteth-20, steareth-20, tetrasodium edta, acacia senegal gum, sodium hydroxide, cichorium intybus (chicory) root extract, alaria esculenta extract, alcohol, lecithin, hydrolyzed soybean fiber, hydroxypropyl cyclodextrin, folic acid, hydrolyzed corn protein, palmitoyl tripeptide-38.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp, Ltd., San Juan,
Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

• FORMULA CREATED BY FRENCH DERMATOLOGISTS
SKIN
EXPERTS

LEDERM

55+  JOUR

facial lotion
against advanced
signs of aging
day lotion SPF 15
all skin types

50 ml e (1.6 fl.oz.)

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-75414141-754-01, 14141-754-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PHENETHYL BENZOATE0C143929GKIACT
CYCLOMETHICONE 50THT5PCI0RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PENTYLENE GLYCOL50C1307PZGIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALBIZIA JULIBRISSIN BARK0J9G6W44DVIACT
PEG-75 STEARATEOT38R0N74HIACT
XANTHAN GUMTTV12P4NEEIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CHLORPHENESINI670DAL4SZIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETETH-20I835H2IHHXIACT
STEARETH-20L0Q8IK9E08IACT
EDETATE SODIUMMP1J8420LUIACT
ACACIA5C5403N26OIACT
SODIUM HYDROXIDE55X04QC32IIACT
CHICORY ROOT090CTY533NIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
ALCOHOL3K9958V90MIACT
FOLIC ACID935E97BOY8IACT
PALMITOYL LYSYLDIOXYMETHIONYLLYSINET7A529FB8OIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

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
0cd52151-1039-6187-e063-6294a90a518628c57e79-b3c1-4a7a-b643-b05df18e005d2023-12-18WarningsExact identifier
spl id: 0cd52151-1039-6187-e063-6294a90a5186
spl set id: 28c57e79-b3c1-4a7a-b643-b05df18e005d

Reported adverse events (FAERS/openFDA)#

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