LBEL

Manufacturer
Ventura International Ltd. | Bel Star, S. A.(Colombia) | Yobel Supply Chain Management (Peru)
Effective date
2011-11-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:47:20

Label at a glance#

ProductLBEL Dermo Clarite
Active ingredientAvobenzone, Ensulizole, Octisalate, Octocrylene, Oxybenzone
Label structure10 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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

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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Butyl methoxydibenzoylmethane 3.0%,

Ensulizole 3.0%,

Octisalate 5.0%,

Octocrylene 5.0%,

Oxybenzone 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED 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.

OTC - DO NOT USE SECTION

  • Do not use on damage 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.
  • Children under 6 months of age: Ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua (water), dicaprylyl carbonate, cetearyl alcohol, phenethyl benzoate, triethanolamine, cyclopentasiloxane, propylene glycol, methyl methacrylate crosspolymer, sorbitan stearate, triethylhexanoin, potassium cetyl phosphate, phenoxyethanol, dimethicone, stearyl dimethicone, ceteareth-20, xanthan gum, chlorphenesin, parfum (fragrance), vigna aconitifolia seed extract, cetyl alcohol, dimethylmethoxy chromanyl palmitate, glyceryl stearate, methylparaben, sodium cocoyl glutamate, tetrasodium edta, peg-75 stearate, butylparaben, sorbic acid, ceteth-20, steareth-20.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L'BEL
DERMO CLARITÉ

clarifying and moisturizing
facial lotion with SPF 30

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box
Principal Display Panel - 30 ml Bottle Box

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
EnsulizoleACTIVE INGREDIENT9YQ9DI1W421
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
EnsulizoleACTIVE MOIETY9YQ9DI1W421
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
alcoholINACTIVE INGREDIENT3K9958V90M1
butylparabenINACTIVE INGREDIENT3QPI1U3FV81
ceteth-20INACTIVE INGREDIENTI835H2IHHX1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
dicaprylyl carbonateINACTIVE INGREDIENT609A3V1SUA1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
edetate sodiumINACTIVE INGREDIENTMP1J8420LU1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
moth beanINACTIVE INGREDIENTH7938ON8E51
peg-75 stearateINACTIVE INGREDIENTOT38R0N74H1
phenethyl benzoateINACTIVE INGREDIENT0C143929GK1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUY1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UT1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
sorbic acidINACTIVE INGREDIENTX045WJ989B1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X1
steareth-20INACTIVE INGREDIENTL0Q8IK9E081
triethylhexanoinINACTIVE INGREDIENT7K3W1BIU6K1
trolamineINACTIVE INGREDIENT9O3K93S3TK1
waterINACTIVE INGREDIENT059QF0KO0R1
xanthan gumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14783-43414783-434-02, 14783-434-01, 14783-434-04, 14783-434-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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 · 389 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / ORAL62.5 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BSOLUTION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
polyoxyl 20 cetostearyl etherPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYSUSPENSION / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / TOPICAL2.15 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
ceteth-20CETETH-20I835H2IHHXSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 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
2fc6faad-729b-eab3-e063-6294a90a32507c0b3e24-fece-4227-89e3-6db7b3e0f6ec2025-03-07WarningsExact identifier
spl set id: 7c0b3e24-fece-4227-89e3-6db7b3e0f6ec

Reported adverse events (FAERS/openFDA)#

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