FDA.reportPublic FDA data

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 2-3

Manufacturer
Yanbal USA, Inc. | Yanbal de Colombia S.A.S. | Unique S.A.
Effective date
2021-04-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:46:10

Label at a glance#

ProductYANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 4-5
Active ingredientTITANIUM DIOXIDE
Label structure11 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating or immediately after towel drying children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.7%

Purpose: Sunscreen

Uses

OTC - PURPOSE 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 prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating or immediately after towel drying
  • children under 6 months: Ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun
  • report serious adverse event to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

INACTIVE INGREDIENT SECTION

TALC, MICA, SYNTHETIC FLUORPHLOGOPITE, ALUMINUM CALCIUM SODIUM SILICATE, ALUMINUM STARCH OCTENYLSUCCINATE, DIISOPROPYL DIMER DILINOLEATE, NYLON 12, ALUMINUM HYDROXIDE, MAGNESIUM MYRISTATE, ACRYLATE COPOLYMER, HYDROGEN DIMETHICONE, ALUMINA, PHENOXYETHANOL, ETHYLHEXYL PALMITATE, DECYLENE GLYCOL, HYDRATED SILICA, MYRICA PUBESCENS FRUIT WAX, SILICA, LUFFA CYLINDRICA SEED OIL, TIN OXIDE, IRON OXIDES (CI 77491/CI 77492/ CI 77499), TITANIUM DIOXIDE (CI 77891) MANGANESE VIOLET (CI 77742), ULTRAMARINES (CI 77007).

Company information

SPL UNCLASSIFIED SECTION

Distributed by YANBAL USA INC. 1341 W Newport Center Dr. Deerfield Beach, FL 33442

Product Packaging - Tono 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

11

Product Packaging - Tono 2-3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

2323

Procut Packaging - Tono 4-5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

4545

Product Packaging - Tono 6-7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

6767

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23319-001323319-0013-1
23319-001423319-0014-1
23319-001523319-0015-1
23319-001623319-0016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 80 matching rows.

Name, UNII, Kind table
NameUNIIKind
LUFFA AEGYPTIACA SEED OIL1A281RJ859IACT
STANNIC OXIDEKM7N50LOS6IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
DECYLENE GLYCOLS57M60MI88IACT
ULTRAMARINE BLUEI39WR998BIIACT
MAGNESIUM MYRISTATEZ1917F0578IACT
FERROUS OXIDEG7036X8B5HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYL PALMITATE2865993309IACT
HYDRATED SILICAY6O7T4G8P9IACT
MORELLA PUBESCENS FRUIT WAX2N43GS24LVIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
MICAV8A1AW0880IACT
ALUMINUM OXIDELMI26O6933IACT
TALC7SEV7J4R1UIACT
DIISOPROPYL DILINOLEATE5323S7S2LRIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
NYLON-12446U8J075BIACT
LUFFA AEGYPTIACA SEED OIL1A281RJ859IACT
STANNIC OXIDEKM7N50LOS6IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
DECYLENE GLYCOLS57M60MI88IACT
ULTRAMARINE BLUEI39WR998BIIACT
MAGNESIUM MYRISTATEZ1917F0578IACT
FERROUS OXIDEG7036X8B5HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYL PALMITATE2865993309IACT
HYDRATED SILICAY6O7T4G8P9IACT
MORELLA PUBESCENS FRUIT WAX2N43GS24LVIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NYLON-12446U8J075BIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
MICAV8A1AW0880IACT
ALUMINUM OXIDELMI26O6933IACT
TALC7SEV7J4R1UIACT
DIISOPROPYL DILINOLEATE5323S7S2LRIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT

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
c0688898-7409-2710-e053-2a95a90a587e785f2b2e-a523-6278-e053-2991aa0a8f072021-04-20WarningsExact identifier
spl id: c0688898-7409-2710-e053-2a95a90a587e
spl set id: 785f2b2e-a523-6278-e053-2991aa0a8f07

Reported adverse events (FAERS/openFDA)#

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