FDA.reportPublic FDA data

LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30

Manufacturer
BEL STAR SA
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:31:27

Label at a glance#

ProductLBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.80%

Octisalate 4.50%

Octocrylene 4.50%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

  • Skin Cancer / Skin Aging Alert: 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, not skin cancer or early skin aging.
  • 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

  • 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, c12-15 alkyl benzoate, butyloctyl salicylate, cyclohexasiloxane, ethylhexyl methoxycrylene, potassium cetyl phosphate, triethylhexanoin, hydrogenated palm glycerides, glyceryl stearate, peg-100 stearate, synthetic fluorphlogopite, hydroxyacetophenone, titanium dioxide, acrylates/c10-30 alkyl acrylate crosspolymer, vigna aconitifolia seed extract, xanthan gum, 1,2-hexanediol, caprylyl glycol, cetearyl isononanoate, sodium cocoyl glutamate, acacia senegal gum, dimethylmethoxy chromanyl palmitate, tetrasodium edta, ceteareth-20, cetearyl alcohol, sodium hydroxide, hydrolyzed algin, ceteareth-12, cetyl palmitate, phenoxyethanol, tin oxide.

Company Information

SPL UNCLASSIFIED SECTION

PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926, U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126 .

www.lbel.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-332-01LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 3030 mL in 1 BOTTLE, GLASSEMULSION303
14141-332-01LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 301 in 1 BOXEMULSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-332LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) EMULSION [BEL STAR SA]3Current NDC, 2 package rows20241030_fd90ffc6-a1e1-e02e-e053-6294a90a4e7c.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-33214141-332-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
MOTH BEANH7938ON8E5IACT
CYCLOMETHICONE 50THT5PCI0RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
STANNOUS OXIDEJB2MV9I3LSIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)0K9R94573CIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
CETYL PALMITATE5ZA2S6B08XIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE SODIUMMP1J8420LUIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ACACIA5C5403N26OIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETEARETH-127V4MR24V5PIACT
OCTOCRYLENE5A68WGF6WMACTIB
DIMETHYLMETHOXY CHROMANYL PALMITATE5G222ZDK7UIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SAfd90ffc6-a1e1-e02e-e053-6294a90a4e7c2024-10-28WarningsExact identifier
ndc (package): 14141-332-01
ndc (product): 14141-332
ndc11 (package): 14141033201
spl id: 258cb0bd-e33d-f054-e063-6294a90a2ae2
spl set id: fd90ffc6-a1e1-e02e-e053-6294a90a4e7c

Reported adverse events (FAERS/openFDA)#

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