FDA.reportPublic FDA data

ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15

Manufacturer
BEL STAR S.A.
Effective date
2026-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:33:01

Label at a glance#

ProductESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure15 sections

Label contents#

Full prescribing information#

Información del medicamento

SPL UNCLASSIFIED SECTION

.Información del medicamento

Ingredientes activos

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 3%
TITANIUM DIOXIDE 6.24%
ZINC OXIDE 4.90%

Propósito

OTC - PURPOSE SECTION

Protector solar

Uso

INDICATIONS & USAGE SECTION

Ayuda a prevenir quemaduras solares

Advertencias

WARNINGS SECTION

  • Alerta de Cáncer en la piel / envejecimiento de la piel : Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que unicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma.
  • Sólo para uso externo.

No usar

OTC - DO NOT USE SECTION

en piel dañada o lastimada.

Cuando use este producto

OTC - WHEN USING SECTION

mantener alejado de los ojos. Enjuagar con agua para eliminar.

Detenga su uso y consulte al doctor

OTC - STOP USE SECTION

si sucede enrojecimiento.

Mantener fuera del alcance de los niños.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente

Instrucciones

DOSAGE & ADMINISTRATION SECTION

  • Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
  • Reaplicar por lo menos cada dos horas.
  • Use un protector solar resistente al agua si usted nada o suda.
  • Niños menores a 6 meses de edad: Consulte al médico

Otra información

OTHER SAFETY INFORMATION

  • Proteja el producto del calor excesivo y del sol directo.

Ingredientes inactivos

INACTIVE INGREDIENT SECTION

MICA, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, MAGNESIUM STEARATE, TRIMETHYLSILOXYSILICATE, ISOSTEARYL NEOPENTANOATE, HYDROGEN DIMETHICONE, PHENOXYETHANOL, GLYCERIN, ALUMINA, TOCOPHERYL ACETATE, FRAGRANCE, CAPRYLYL GLYCOL, CERAMIDE NP, CHLORPHENESIN, SILICA, NIACINAMIDE, LINALOOL, HYDROXYCITRONELLAL, TERPINEOL, CITRONELLOL, GERANIOL, LIMONENE, ALPHA-ISOMETHYL IONONE.
Puede Contener:
TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE.

110-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

110-C

110c110c

180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180-F

180f180f

200-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200-C

200c200c

220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

220-C

220c220c

270-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

270-C

270c270c

310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

310-C

310c310c

420-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

420-C

420c420c

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-59214141-592-01
14141-59514141-595-01
14141-59414141-594-01
14141-59614141-596-01
14141-59814141-598-01
14141-59314141-593-01
14141-59714141-597-01

Ingredients#

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

DailyMed ingredient rows page 1 of 6 · 217 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
MICAV8A1AW0880IACT
POLYMETHYLSILSESQUIOXANE (2 MICRONS)CU6UV43RBAIACT
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM STEARATE70097M6I30IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.66)5041RX63GNIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
ALUMINALMI26O6933IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CERAMIDE NP4370DF050BIACT
CHLORPHENESINI670DAL4SZIACT
SILICAETJ7Z6XBU4IACT
NIACINAMIDE25X51I8RD4IACT
LINALOOL, (+)-F4VNO44C09IACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
TERPINEOLR53Q4ZWC99IACT
CITRONELLOLP01OUT964KIACT
GERANIOLL837108USYIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALPHA-ISOMETHYL IONONE9XP4LC555BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CI 774911K09F3G675IACT
CI 77492EX438O2MRTIACT
CI 77499XM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
MICAV8A1AW0880IACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINALMI26O6933IACT

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
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
ndc (package): 14141-598-01
ndc (package): 14141-593-01
ndc (package): 14141-592-01
ndc (package): 14141-597-01
ndc (package): 14141-596-01
ndc (package): 14141-595-01
ndc (package): 14141-594-01
ndc (product): 14141-594
ndc (product): 14141-592
ndc (product): 14141-598
ndc (product): 14141-597
ndc (product): 14141-596
ndc (product): 14141-595
ndc (product): 14141-593
ndc11 (package): 14141059601
ndc11 (package): 14141059401
ndc11 (package): 14141059201
ndc11 (package): 14141059701
ndc11 (package): 14141059501
ndc11 (package): 14141059301
ndc11 (package): 14141059801
spl id: 575fb2c3-e333-8a3b-e063-6394a90a9fd9
spl set id: 575fb2c3-e332-8a3b-e063-6394a90a9fd9

Reported adverse events (FAERS/openFDA)#

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