FDA.reportPublic FDA data

octinoxate

Manufacturer
Yanbal USA, Inc. | Yanbal de Colombia S.A.S.
Effective date
2022-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:47:20

Label at a glance#

ProductYANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING 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 3%

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

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
  • 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

AQUA/WATER, CYCLOPENTASILOXANE, BIS-PEG/PPG-14/14 DIMETHICONE, TRIETHYLHEXANOIN, DIMETHICONE, BUTYLENE GLYCOL, C10-30 CHOLESTEROL/LANOSTEROL ESTERS, GLYCERIN, ISOHEXADECANE, SODIUM CHLORIDE, TALC, C30-45 ALKYLDIMETHYLSILYL POLYPROPYLSILSESQUIOXANE, TRIMETHYLSILOXYSILICATE, DIMETHICONOL, PARFUM/FRAGRANCE, NYLON 12, DISTEARDIMONIUM HECTORITE, POLYPROPYLSILSESQUIOXANE, XANTHAN GUM, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, PROPYLENE CARBONATE, DISODIUM EDTA, MAGNESIUM SULFATE, MICA, CHLORPHENESIN, MYRICA PUBESCENS FRUIT WAX, C26-28 ALKYL DIMETHICONE, ALPINIA GALANGA LEAF EXTRACT, SODIUM HYALURONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, TIN OXIDE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491/CI 77492/CI 77499).

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 HIDRATANTE

MOISTURIZING 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 HIDRATANTE

MOISTURIZING 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 HIDRATANTE

MOISTURIZING 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 HIDRATANTE

MOISTURIZING 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 HIDRATANTE

MOISTURIZING 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 HIDRATANTE

MOISTURIZING 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 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23319-000123319-0001-1
23319-000223319-0002-1
23319-000323319-0003-1
23319-000423319-0004-1
23319-000523319-0005-1
23319-000623319-0006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 180 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNIC OXIDEKM7N50LOS6IACT
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.66)5041RX63GNIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
HYALURONATE SODIUMYSE9PPT4THIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
BIS-PEG/PPG-14/14 DIMETHICONEX2I70H0QJEIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
TALC7SEV7J4R1UIACT
DIMETHICONOL (40 CST)343C7U75XWIACT
NYLON-12446U8J075BIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
OCTINOXATE4Y5P7MUD51ACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPYLENE CARBONATE8D08K3S51EIACT
MICAV8A1AW0880IACT
CHLORPHENESINI670DAL4SZIACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
SODIUM CHLORIDE451W47IQ8XIACT
EDETATE DISODIUM7FLD91C86KIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
MORELLA PUBESCENS FRUIT WAX2N43GS24LVIACT
FERROUS OXIDEG7036X8B5HIACT
STANNIC OXIDEKM7N50LOS6IACT
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.66)5041RX63GNIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
HYALURONATE SODIUMYSE9PPT4THIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
BIS-PEG/PPG-14/14 DIMETHICONEX2I70H0QJEIACT
DIMETHICONE92RU3N3Y1OIACT

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
ede96586-e4f3-7456-e053-2a95a90a897c77e6b4dd-ebdb-7963-e053-2991aa0a85f72022-11-20WarningsExact identifier
spl id: ede96586-e4f3-7456-e053-2a95a90a897c
spl set id: 77e6b4dd-ebdb-7963-e053-2991aa0a85f7

Reported adverse events (FAERS/openFDA)#

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