FDA.reportPublic FDA data

ÉSIKA TRIPLE ACCIÓN MAX BB CREAM

Manufacturer
Ventura Corporation LTD | Bel Star S.A. (Colombia)
Effective date
2014-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:37:03

Label at a glance#

ProductESIKA TRIPLE ACCION MAX BB Light Beige
Active ingredientZinc Oxide, Octinoxate
Label structure10 sections

Storage and handling

Proteja el producto del calor excesivo y del sol directo.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Información del medicamento

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Ingredientes activosPropósito
Zinc Oxide 8.4 %Protector solar
Ethylhexyl Methoxycinnamate 7.0%Protector solar

Uso

INDICATIONS & USAGE SECTION

  • Ayuda a prevenir quemaduras solares

Advertencias

WARNINGS SECTION

SPL UNCLASSIFIED 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.

OTC - DO NOT USE SECTION

  • No usar en piel dañada o lastimada.

OTC - WHEN USING SECTION

  • Cuando use este producto mantener alejado de los ojos. Enjuagar con agua para eliminar.

OTC - STOP USE SECTION

  • Detenga su uso y consulte al doctor si sucede enrojecimiento.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Mantener fuera del alcance de los niños. 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

STORAGE AND HANDLING SECTION

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

Ingredientes inactivos

INACTIVE INGREDIENT SECTION

Aqua (Water),Dimethicone, PEG-10,Dimethicone, Propylene Glycol, Benzimidazole Diamond Amidoethyl Urea, Carbamoyl Propyl Polymethylsilsesquioxane, Polysilicone-11, PEG/PPG-18/18 Dimethicone, Silica, Phenoxyethanol, Polymethylsilsesquioxane, HDI/TRIMETHYLOL Hexyllactone Crosspolymer, Sodium Chloride, Caprylyl Glycol, Chlorphenesin, Disteardimonium Hectorite, Phenethyl Alcohol, PPG-2,Methyl Ether, Sodium Hyaluronate, Methylisothiazolinone. Puede Contener:CI 77891 (Titanium Dioxide ) , CI 77492 ( Iron Oxides), CI 77491 (Iron Oxides),CI 77499 (Iron Oxides), Triethoxycaprylylsilane.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton - Light Beige

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIPLE ACCIÓN
max

BB
CREAM

CREMA FACIAL
PERFECCIONADORA
CON COLOR FPS 30
6 BENEFICIOS EN 1

ésika

30 g e (1 oz.)

Principal Display Panel - 30 g Tube Carton - Light Beige
Principal Display Panel - 30 g Tube Carton - Light Beige

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton - Dark Beige

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIPLE ACCIÓN
max

BB
CREAM

CREMA FACIAL
PERFECCIONADORA
CON COLOR FPS 30
6 BENEFICIOS EN 1

ésika

30 g e (1 oz.)

Principal Display Panel - 30 g Tube Carton - Dark Beige
Principal Display Panel - 30 g Tube Carton - Dark Beige

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-998-052025-04-30C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM
13537-998-062025-04-30C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM
13537-999-022025-04-30C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM
13537-999-032025-04-30C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM
13537-998-052019-11-27C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM
13537-998-062019-11-27C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM
13537-999-022019-11-27C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM
13537-999-032019-11-27C16284748780-19855e2a2-496e-60a7-e053-dbdaa90a05bdÉSIKA TRIPLE ACCIÓN MAX BB CREAM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OctinoxateACTIVE MOIETY4Y5P7MUD511
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Dimethyl EtherINACTIVE INGREDIENTAM13FS69BX1
Disteardimonium HectoriteINACTIVE INGREDIENTX687XDK09L1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6751
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRT1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F3571
Hyaluronate SodiumINACTIVE INGREDIENTYSE9PPT4TH1
MethylisothiazolinoneINACTIVE INGREDIENT229D0E1QFA1
PEG/PPG-18/18 DimethiconeINACTIVE INGREDIENT9H0AO7T7941
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Phenylethyl AlcoholINACTIVE INGREDIENTML9LGA74681
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13537-99913537-999-01, 13537-999-02, 13537-999-03
13537-99813537-998-04, 13537-998-05, 13537-998-06

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Octinoxate4Y5P7MUD51ACTIB
Water059QF0KO0RIACT
Dimethicone92RU3N3Y1OIACT
Propylene Glycol6DC9Q167V3IACT
PEG/PPG-18/18 Dimethicone9H0AO7T794IACT
Silicon DioxideETJ7Z6XBU4IACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium Chloride451W47IQ8XIACT
Caprylyl Glycol00YIU5438UIACT
ChlorphenesinI670DAL4SZIACT
Disteardimonium HectoriteX687XDK09LIACT
Phenylethyl AlcoholML9LGA7468IACT
Dimethyl EtherAM13FS69BXIACT
Hyaluronate SodiumYSE9PPT4THIACT
Methylisothiazolinone229D0E1QFAIACT
Titanium Dioxide15FIX9V2JPIACT
Ferric Oxide YellowEX438O2MRTIACT
Ferric Oxide Red1K09F3G675IACT
Ferrosoferric OxideXM0M87F357IACT
TriethoxycaprylylsilaneLDC331P08EIACT
Zinc OxideSOI2LOH54ZACTIB
Octinoxate4Y5P7MUD51ACTIB
Water059QF0KO0RIACT
Dimethicone92RU3N3Y1OIACT
Propylene Glycol6DC9Q167V3IACT
PEG/PPG-18/18 Dimethicone9H0AO7T794IACT
Silicon DioxideETJ7Z6XBU4IACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium Chloride451W47IQ8XIACT
Caprylyl Glycol00YIU5438UIACT
ChlorphenesinI670DAL4SZIACT
Disteardimonium HectoriteX687XDK09LIACT
Phenylethyl AlcoholML9LGA7468IACT
Dimethyl EtherAM13FS69BXIACT
Hyaluronate SodiumYSE9PPT4THIACT
Methylisothiazolinone229D0E1QFAIACT
Titanium Dioxide15FIX9V2JPIACT
Ferric Oxide YellowEX438O2MRTIACT
Ferric Oxide Red1K09F3G675IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 377 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
134 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii candidate
134 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
Phenylethyl AlcoholPHENYLETHYL ALCOHOLML9LGA7468SUSPENSION / INTRA-ARTICULAR5 mgExact identifier — unii candidate
9 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii candidate
134 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Hyaluronate SodiumHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAMUSCULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAPERITONEAL0.54 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
10 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hyaluronate SodiumHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
Phenylethyl AlcoholPHENYLETHYL ALCOHOLML9LGA7468CREAM / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / BUCCAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates

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
33a19ede-78d8-c21d-e063-6294a90a1e3b269c7e12-ca28-40bf-88a1-4138ef6925432025-04-25WarningsExact identifier
spl set id: 269c7e12-ca28-40bf-88a1-4138ef692543

Reported adverse events (FAERS/openFDA)#

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