ESIKA

Manufacturer: Ventura Corporation LTD | Bel Star S.A. (Colombia)
Effective date: 2013-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:38:34

Label at a glance#

ProductESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50

Active ingredientEnsulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide

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
Ensulizole (3%)	Sunscreen
Octinoxate (7.5%)	Sunscreen
Octisalate (5%)	Sunscreen
Octocrylene (7%)	Sunscreen
Oxybenzone (6%)	Sunscreen
Titanium Dioxide (4.7%)	Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer / Skin Aging Alert: 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.

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), arginine, butylparaben, ceteareth-20, cetearyl alcohol, cyclohexasiloxane, cyclopentasiloxane, dicaprylyl carbonate, dimethicone, disodium lauriminodipropionate tocopheryl phosphates, ethylparaben, glyceryl stearate, isobutylparaben, methicone, methyl methacrylate crosspolymer, methylparaben, parfum (fragrance), phenethyl benzoate, phenoxyethanol, potassium cetyl phosphate, propylparaben, silica, sorbitan stearate, trimethylsiloxysilicate, vp/eicosene copolymer, xanthan gum.

SPL UNCLASSIFIED SECTION

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF
50

Perfect
sun
Kids

Sunscreen

protector against solar
rays for children, face and
body SPF 50

ēsika

80 ml e (2.7 fl.oz.)

PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-224-01	2025-05-01	C162847	48780-1	9855e2a2-4c80-60a7-e053-dbdaa90a05bd	ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50
13537-224-01	2019-11-27	C162847	48780-1	9855e2a2-4c80-60a7-e053-dbdaa90a05bd	ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ensulizole	ACTIVE INGREDIENT	9YQ9DI1W42	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
Ensulizole	ACTIVE MOIETY	9YQ9DI1W42	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	1
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	1
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES	INACTIVE INGREDIENT	0K5Y9U1P6M	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PHENETHYL BENZOATE	INACTIVE INGREDIENT	0C143929GK	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50
Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium Dioxide
Ensulizole
Octinoxate
Octisalate
Octocrylene
Oxybenzone
Titanium Dioxide
WATER
ARGININE
BUTYLPARABEN
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
CYCLOMETHICONE 6
CYCLOMETHICONE 5
DICAPRYLYL CARBONATE
DIMETHICONE
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES
ETHYLPARABEN
GLYCERYL MONOSTEARATE
ISOBUTYLPARABEN
METHYLPARABEN
PHENETHYL BENZOATE
PHENOXYETHANOL
POTASSIUM CETYL PHOSPHATE
PROPYLPARABEN
SILICON DIOXIDE
SORBITAN MONOSTEARATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13537-224	13537-224-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Ensulizole	9YQ9DI1W42	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Octisalate	4X49Y0596W	ACTIB
Octocrylene	5A68WGF6WM	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Titanium Dioxide	15FIX9V2JP	ACTIB
WATER	059QF0KO0R	IACT
ARGININE	94ZLA3W45F	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CYCLOMETHICONE 6	XHK3U310BA	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
DICAPRYLYL CARBONATE	609A3V1SUA	IACT
DIMETHICONE	92RU3N3Y1O	IACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES	0K5Y9U1P6M	IACT
ETHYLPARABEN	14255EXE39	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PHENETHYL BENZOATE	0C143929GK	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POTASSIUM CETYL PHOSPHATE	03KCY6P7UT	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
XANTHAN GUM	TTV12P4NEE	IACT

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 6 · 312 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUSPENSION / ORAL	62.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	POWDER, FOR SOLUTION / INTRAVENOUS	7.07 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	TABLET, FILM COATED / ORAL		25 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3416929e-4aef-b782-e063-6394a90ab930			80ebd69c-5185-403a-91cd-aff31157f3b5	2025-05-01	Warnings	Exact identifier spl set id: 80ebd69c-5185-403a-91cd-aff31157f3b5

Reported adverse events (FAERS/openFDA)#

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