FDA.reportPublic FDA data

TITANIUM DIOXIDE, ZINC OXIDE

Manufacturer
BEL STAR S A
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:41

Label at a glance#

ProductLBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure14 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

Titanium Dioxide 5.75%

Zinc Oxide 4.90%

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

Mica, dimethicone, polymethylsilsesquioxane, zinc stearate, hdi/trimethylol hexyllactone crosspolymer, trimethylsiloxysilicate, caprylic/capric triglyceride, perfluorohexylethyl triethoxysilane, tocopheryl acetate, hydrogen dimethicone, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, alumina, hexyl laurate, fragrance, caprylyl glycol, crithmum maritimum extract, triethoxycaprylylsilane, chlorphenesin, ceramide np, hydroxycitronellal, linalool, citronellol, geraniol, alpha-isomethyl ionone, limonene.

May Contain: Iron oxides, titanium dioxide.

Company Information

SPL UNCLASSIFIED SECTION

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

Made in Colombia.

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

Made in Colombia.

www.lbel.com

Product Packaging PERLA 100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

perla 100perla 100

Product Packaging ARENA 200

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

arena 200arena 200

Product Packaging CARAMEL 200

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

caramel 200caramel 200

Product Packaging SOLEI 200

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

solei 200solei 200

Product Packaging AVELLANA 200

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

avellana 200avellana 200

Product Packaging GOLDEN 300

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

golden 300golden 300

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-300-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 1001 in 1 BOXPOWDER14
14141-300-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 10010 g in 1 CASEPOWDER104
14141-301-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 20010 g in 1 CASEPOWDER104
14141-301-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 2001 in 1 BOXPOWDER14
14141-302-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 20010 g in 1 CASEPOWDER104
14141-302-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 2001 in 1 BOXPOWDER14
14141-303-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 2001 in 1 BOXPOWDER14
14141-303-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 20010 g in 1 CASEPOWDER104
14141-304-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 20010 g in 1 CASEPOWDER104
14141-304-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 2001 in 1 BOXPOWDER14
14141-305-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 3001 in 1 BOXPOWDER14
14141-305-01LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 30010 g in 1 CASEPOWDER104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-300LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BEL STAR S A]4Current NDC, Legacy NDC, 2 package rows20241207_e4bb5a32-c5dc-86d5-e053-2a95a90a4938.zip
14141-301LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BEL STAR S A]4Current NDC, Legacy NDC, 2 package rows20241207_e4bb5a32-c5dc-86d5-e053-2a95a90a4938.zip
14141-302LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BEL STAR S A]4Current NDC, Legacy NDC, 2 package rows20241207_e4bb5a32-c5dc-86d5-e053-2a95a90a4938.zip
14141-303LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BEL STAR S A]4Current NDC, Legacy NDC, 2 package rows20241207_e4bb5a32-c5dc-86d5-e053-2a95a90a4938.zip
14141-304LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BEL STAR S A]4Legacy NDC, 2 package rows20241207_e4bb5a32-c5dc-86d5-e053-2a95a90a4938.zip
14141-305LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BEL STAR S A]4Current NDC, Legacy NDC, 2 package rows20241207_e4bb5a32-c5dc-86d5-e053-2a95a90a4938.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-30014141-300-01
14141-30514141-305-01
14141-30114141-301-01
14141-30214141-302-01
14141-30314141-303-01
14141-30414141-304-01

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 186 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PERFLUOROOCTYL TRIETHOXYSILANE814P46684UIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
CHLORPHENESINI670DAL4SZIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC OXIDESOI2LOH54ZACTIB
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
MICAV8A1AW0880IACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
GERANIOLL837108USYIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
CRITHMUM MARITIMUM WHOLEJ7IHY79BKYIACT
CERAMIDE NP4370DF050BIACT
DIMETHICONE92RU3N3Y1OIACT
ALUMINUM OXIDELMI26O6933IACT
HEXYL LAURATE4CG9F9W01QIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+/-)-9MC3I34447IACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC STEARATEH92E6QA4FVIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
GERANIOLL837108USYIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
CRITHMUM MARITIMUM WHOLEJ7IHY79BKYIACT
CERAMIDE NP4370DF050BIACT
ALUMINUM OXIDELMI26O6933IACT
HEXYL LAURATE4CG9F9W01QIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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 FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S Ae4bb5a32-c5dc-86d5-e053-2a95a90a49382024-12-04WarningsExact identifier
ndc (package): 14141-305-01
ndc (package): 14141-304-01
ndc (package): 14141-301-01
ndc (package): 14141-302-01
ndc (package): 14141-300-01
ndc (package): 14141-303-01
ndc (product): 14141-302
ndc (product): 14141-305
ndc (product): 14141-303
ndc (product): 14141-301
ndc (product): 14141-300
ndc (product): 14141-304
ndc11 (package): 14141030001
ndc11 (package): 14141030501
ndc11 (package): 14141030301
ndc11 (package): 14141030101
ndc11 (package): 14141030401
ndc11 (package): 14141030201
spl id: 287dfcb8-6041-ca1f-e063-6394a90a8f6f
spl set id: e4bb5a32-c5dc-86d5-e053-2a95a90a4938

Reported adverse events (FAERS/openFDA)#

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