FDA.reportPublic FDA data

AVOBENZONE, OCTISALATE, OCTOCRYLENE

Manufacturer
BEL STAR S A
Effective date
2022-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:51:47

Label at a glance#

ProductLBEL DERMO CLARITE LOCION FACIAL ILUMINADORA HIDRATANTE CON FPS 30 BRIGHTENING AND MOISTURIZING FACIAL SPF 30
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTISALATE
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

OTC - STOP USE SECTION

if 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

U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126 Made in Colombia.

PUERTO RICO: Dist. by Ventura Corp. Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

www.lbel.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-31514141-315-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARETH-127V4MR24V5PIACT
CETYL PALMITATE5ZA2S6B08XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
MOTH BEANH7938ON8E5IACT
XANTHAN GUMTTV12P4NEEIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DISODIUM COCOYL GLUTAMATEMBK0CP8F5AIACT
DIMETHYLMETHOXY CHROMANYL PALMITATE5G222ZDK7UIACT
EDETATE SODIUMMP1J8420LUIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CYCLOMETHICONE 6XHK3U310BAIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STANNOUS OXIDEJB2MV9I3LSIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
ACACIA5C5403N26OIACT
OCTISALATE4X49Y0596WACTIB

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
287dfa37-8fd3-cafb-e063-6394a90a79faea79d363-6761-0bac-e053-2a95a90af8bb2024-12-04WarningsExact identifier
spl set id: ea79d363-6761-0bac-e053-2a95a90af8bb

Reported adverse events (FAERS/openFDA)#

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