FDA.reportPublic FDA data

ESIKA

Manufacturer
Ventura Corporation Ltd | Bel Star S.A. (Colombia)
Effective date
2013-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:40:06

Label at a glance#

ProductESIKA NATURAL CARE
Active ingredientOctinoxate, Oxybenzone
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients Purpose
OCTINOXATE 7.5%Sunscreen
OXYBENZONE 4.5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

Skin Cancer / Skin Aging Alert

SPL UNCLASSIFIED SECTION

  • Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

OTC - WHEN USING SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA (WATER), GLYCERYL STEARATE, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, PEG-100 STEARATE, CETYL ALCOHOL, DICAPRYLYL CARBONATE, PROPYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, CYCLOHEXASILOXANE, DIMETHICONE, METHYLPARABEN, CI 77891 (TITANIUM DIOXIDE ), PAPAIN, TRIETHANOLAMINE, PROPYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM LACTATE, CASTORYL MALEATE, PARFUM (FRAGRANCE), BUTYLENE GLYCOL, TETRASODIUM EDTA, CALCIUM PANTOTHENATE, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, XANTHAN GUM, BUTYLPARABEN, ETHYLPARABEN, CAPRYLYL GLYCOL, ROSA MOSCHATA SEED OIL, UREA, MAGNESIUM LACTATE, ETHYLHEXYLGLYCERIN, POTASSIUM LACTATE, ISOBUTYLPARABEN, ALANINE, MAGNESIUM CHLORIDE, PROLINE, SERINE, SODIUM CITRATE, MOTHER OF PEARL EXTRACT.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Corporation, Ltd. San
Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 60 g Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

naturalcare

rosa mosqueta
& concha de nácar

crema aclaradora facial FPS 15

60 g e (2.1 oz.)

ésika

Principal Display Panel - 60 g Bottle Carton
Principal Display Panel - 60 g Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-152-012025-04-30C16284748780-19855d018-d4b7-cd31-e053-dbdaa90ab51aésika natural care
13537-152-012019-11-27C16284748780-19855d018-d4b7-cd31-e053-dbdaa90ab51aésika natural care

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD512
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y2
OctinoxateACTIVE MOIETY4Y5P7MUD512
OxybenzoneACTIVE MOIETY95OOS7VE0Y2
ALANINEINACTIVE INGREDIENTOF5P57N2ZX2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
ARCTOSTAPHYLOS UVA-URSI LEAFINACTIVE INGREDIENT3M5V3D1X362
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV82
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3D2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA2
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
ETHYLPARABENINACTIVE INGREDIENT14255EXE392
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PAPAININACTIVE INGREDIENTA236A06Y322
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POTASSIUM LACTATEINACTIVE INGREDIENT87V1KMK4QV2
PROLINEINACTIVE INGREDIENT9DLQ4CIU6V2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
ROSA MOSCHATA SEED OILINACTIVE INGREDIENTT031ZE559T2
SERINEINACTIVE INGREDIENT452VLY94022
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
UREAINACTIVE INGREDIENT8W8T17847W2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13537-15213537-152-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CYCLOMETHICONE 6XHK3U310BAIACT
DIMETHICONE92RU3N3Y1OIACT
METHYLPARABENA2I8C7HI9TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PAPAINA236A06Y32IACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LACTATETU7HW0W0QTIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE SODIUMMP1J8420LUIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36IACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLPARABEN3QPI1U3FV8IACT
ETHYLPARABEN14255EXE39IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ROSA MOSCHATA SEED OILT031ZE559TIACT
UREA8W8T17847WIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM LACTATE87V1KMK4QVIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
ALANINEOF5P57N2ZXIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PROLINE9DLQ4CIU6VIACT
SERINE452VLY9402IACT
SODIUM CITRATE1Q73Q2JULRIACT

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 9 · 505 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSUSPENSION / AURICULAR (OTIC)0.06 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
UREAUREA8W8T17847WTABLET, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAVENOUS5 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 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
3400e8bb-abd5-c3d2-e063-6394a90a21e9340d1267-0d2a-44fb-9ea7-304ab77bcc322025-04-30WarningsExact identifier
spl set id: 340d1267-0d2a-44fb-9ea7-304ab77bcc32

Reported adverse events (FAERS/openFDA)#

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