FDA.reportPublic FDA data

LBEL

Manufacturer
Ventura International LTD | Bel Star S.A. (Colombia)
Effective date
2013-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:38:34

Label at a glance#

ProductLBEL Lip Moisturizer SPF 18
Active ingredientOctinoxate, Oxybenzone, Titanium Dioxide
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
Octinoxate 7.0%Sunscreen
Oxybenzone 3.0%Sunscreen
Titanium Dioxide 0.8%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.

OTC - WHEN USING SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash 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

Octyldodecanol, caprylic/capric triglyceride, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), copernicia cerifera cera (copernicia cerifera (carnauba) wax), butyrospermum parkii butter (butyrospermum parkii (shea) butter), hydrogenated polyisobutene, silica, propylparaben, cera microcristallina (microcrystalline wax), aqua (water), tocopheryl acetate, petrolatum, phospholipids, bht, parfum (fragrance), cholesterol, crambe maritima extract, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, maltodextrin, zea mays starch (zea mays(corn) starch), phenoxyethanol, sodium hyaluronate, methylparaben, butylparaben, ethylparaben, isobutylparaben.

SPL UNCLASSIFIED SECTION

US: Distributed by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EFFET PARFAIT

lip moisturizer SPF 18

Net Weight 0.14 oz. (4 g)
L'BEL

Principal Display Panel - 4 g Tube Carton
Principal Display Panel - 4 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14783-226-022025-05-19C16284748780-19855e2a2-43ad-60a7-e053-dbdaa90a05bdL'BEL Lip Moisturizer SPF 18
14783-226-022019-11-27C16284748780-19855e2a2-43ad-60a7-e053-dbdaa90a05bdL'BEL Lip Moisturizer SPF 18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171K1
butylparabenINACTIVE INGREDIENT3QPI1U3FV81
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX191
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
cetearyl glucosideINACTIVE INGREDIENT09FUA47KNA1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S1
cholesterolINACTIVE INGREDIENT97C5T2UQ7J1
ethylparabenINACTIVE INGREDIENT14255EXE391
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4TH1
isobutylparabenINACTIVE INGREDIENT0QQJ25X58G1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7U1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
OctyldodecanolINACTIVE INGREDIENT461N1O614Y1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
polyglyceryl-2 dipolyhydroxystearateINACTIVE INGREDIENT9229XJ4V121
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14783-22614783-226-01, 14783-226-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
Titanium Dioxide15FIX9V2JPACTIB
Octyldodecanol461N1O614YIACT
medium-chain triglyceridesC9H2L21V7UIACT
CANDELILLA WAXWL0328HX19IACT
CARNAUBA WAXR12CBM0EIZIACT
SHEA BUTTERK49155WL9YIACT
silicon dioxideETJ7Z6XBU4IACT
propylparabenZ8IX2SC1OHIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
water059QF0KO0RIACT
.alpha.-tocopherol acetate9E8X80D2L0IACT
petrolatum4T6H12BN9UIACT
butylated hydroxytoluene1P9D0Z171KIACT
cholesterol97C5T2UQ7JIACT
cetostearyl alcohol2DMT128M1SIACT
cetearyl glucoside09FUA47KNAIACT
polyglyceryl-2 dipolyhydroxystearate9229XJ4V12IACT
maltodextrin7CVR7L4A2DIACT
STARCH, CORNO8232NY3SJIACT
phenoxyethanolHIE492ZZ3TIACT
hyaluronate sodiumYSE9PPT4THIACT
methylparabenA2I8C7HI9TIACT
butylparaben3QPI1U3FV8IACT
ethylparaben14255EXE39IACT
isobutylparaben0QQJ25X58GIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 382 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED, EXTENDED RELEASE / ORAL140 mgExact identifier — unii candidate
11 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
OctyldodecanolOCTYLDODECANOL461N1O614YFILM, EXTENDED RELEASE / TRANSDERMAL253.4 mgExact identifier — unii candidate
9 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
15 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
OctyldodecanolOCTYLDODECANOL461N1O614YGEL / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
cholesterolCHOLESTEROL97C5T2UQ7JINJECTABLE, LIPOSOMAL / INTRAVENOUS437 mgExact identifier — unii candidate
10 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
OctyldodecanolOCTYLDODECANOL461N1O614YSYSTEM / TRANSDERMAL4.05 mgExact identifier — unii candidate
9 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
OctyldodecanolOCTYLDODECANOL461N1O614YSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
cholesterolCHOLESTEROL97C5T2UQ7JINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL7 mgExact identifier — unii candidate
10 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
OctyldodecanolOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
4 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
9 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates

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
358829f8-46f2-d18b-e063-6394a90a341f4470cd1c-d494-43ef-ae9e-bdcd4e03bc5e2025-05-19WarningsExact identifier
spl set id: 4470cd1c-d494-43ef-ae9e-bdcd4e03bc5e

Reported adverse events (FAERS/openFDA)#

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