FDA.reportPublic FDA data

octinoxate

Manufacturer
Yanbal USA, Inc. | Yanbal de Colombia S.A.S.
Effective date
2023-05-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:31:08

Label at a glance#

ProductYANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 1
Active ingredientOCTINOXATE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 4%

Purpose: Sunscreen

Uses

OTC - PURPOSE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

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

INDICATIONS & USAGE 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
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • 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

WATER (AQUA), CYCLOPENTASILOXANE, ALCOHOL DENAT., ISONONYL ISONONANOATE, PEG-10 DIMETHICONE, BUTYLENE GLYCOL, KAOLIN, DIMETHICONE, DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, MAGNESIUM SULFATE, TRIMETHYLSILOXYSILICATE, ALUMINUM STARCH OCTENYLSUCCINATE, DIPENTAERYTHRITYL TETRABEHENATE/POLYHYDROXYSTEARATE, SODIUM CHLORIDE, FRAGRANCE (PARFUM), DIMETHICONE/PEG-10/15 CROSSPOLYMER, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, XANTHAN GUM, TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE, PROPYLENE CARBONATE, DISODIUM EDTA, CHLORPHENESIN, MYRICA PUBESCENS FRUIT WAX, RETINYL PALMITATE, ENANTIA CHLORANTHA BARK EXTRACT, OLEANOLIC ACID, MICA, IRON OXIDES (CI 77491/CI 77492/CI 77499), TITANIUM DIOXIDE (CI 77891).

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

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

11

Product Packaging - Tono 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

22

Product Packaging - Tono 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

33

Product Packaging - Tono 4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

44

Product Packaging - Tono 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

55

Product Packaging - Tono 7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

77

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23319-000723319-0007-1
23319-000823319-0008-1
23319-000923319-0009-1
23319-001023319-0010-1
23319-001123319-0011-1
23319-001223319-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 168 matching rows.

Name, UNII, Kind table
NameUNIIKind
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MORELLA PUBESCENS FRUIT WAX2N43GS24LVIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
ANNICKIA CHLORANTHA BARKH70115MP4AIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE92RU3N3Y1OIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CHLORPHENESINI670DAL4SZIACT
FERROUS OXIDEG7036X8B5HIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM7FLD91C86KIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
KAOLIN24H4NWX5COIACT
MICAV8A1AW0880IACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE CARBONATE8D08K3S51EIACT
OLEANOLIC ACID6SMK8R7TGJIACT
OCTINOXATE4Y5P7MUD51ACTIB
ALCOHOL3K9958V90MIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
MICAV8A1AW0880IACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE CARBONATE8D08K3S51EIACT
OCTINOXATE4Y5P7MUD51ACTIB
ALCOHOL3K9958V90MIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MORELLA PUBESCENS FRUIT WAX2N43GS24LVIACT
OLEANOLIC ACID6SMK8R7TGJIACT
WATER059QF0KO0RIACT

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
fc0d0c0e-a419-bdcd-e053-6294a90ab06b77e6b501-8cb5-ffae-e053-2991aa0a24a92023-05-19WarningsExact identifier
spl id: fc0d0c0e-a419-bdcd-e053-6294a90ab06b
spl set id: 77e6b501-8cb5-ffae-e053-2991aa0a24a9

Reported adverse events (FAERS/openFDA)#

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