Ensulizole

Manufacturer: Ventura Corporation LTD | Bel Star S.A. (Colombia)
Effective date: 2015-10-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:30:15

Label at a glance#

ProductPerfect Sun Kids Sunscreen protector against solar rays for children, face and body SPF 50 FM

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 (3.00 %)	Sunscreen
Octinoxate (7.50 %)	Sunscreen
Octisalate (5.00 %)	Sunscreen
Octocrylene (7.00 % )	Sunscreen
Oxybenzone (6.00 %)	Sunscreen
Titanium Dioxide (4.68 %)	Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED 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

WATER, DICAPRYLYL CARBONATE, VP/EICOSENE COPOLYMER, PHENETHYL BENZOATE, ARGININE, CYCLOHEXASILOXANE, CETEARYL ALCOHOL, SORBITAN STEARATE, DIMETHICONE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, TRIMETHYLSILOXYSILICATE, SILICA, DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES, HYDROXYACETOPHENONE, METHYL METHACRYLATE CROSSPOLYMER, METHICONE, CETEARETH-20, 1,2 – HEXANEDIOL, CAPRYLYL GLYCOL, XANTHAN GUM, FRAGRANCE, CYCLOPENTASILOXANE.

SPL UNCLASSIFIED SECTION

PUERTO RICO: Dist. by Ventura Corp, 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 FM

ésika

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
13537-387-02	2025-04-25	C162847	48780-1	9d75b9d0-4f0f-f424-e053-dadaa90a57ce	Perfect Sun Kids Sunscreen protector against solar rays for children, face and body SPF 50 FM
13537-387-02	2020-01-31	C162847	48780-1	9d75b9d0-4f0f-f424-e053-dadaa90a57ce	Perfect Sun Kids Sunscreen protector against solar rays for children, face and body SPF 50 FM

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
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	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
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
METHICONE (20 CST)	INACTIVE INGREDIENT	6777U11MKT	1
PHENETHYL BENZOATE	INACTIVE INGREDIENT	0C143929GK	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	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 · 26 matching rows.

Perfect Sun Kids Sunscreen protector against solar rays for children, face and body SPF 50 FM
Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium Dioxide
Ensulizole
Octinoxate
Octisalate
Octocrylene
Oxybenzone
Titanium Dioxide
WATER
DICAPRYLYL CARBONATE
PHENETHYL BENZOATE
ARGININE
CYCLOMETHICONE 6
CETOSTEARYL ALCOHOL
SORBITAN MONOSTEARATE
DIMETHICONE
GLYCERYL MONOSTEARATE
POTASSIUM CETYL PHOSPHATE
SILICON DIOXIDE
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES
METHICONE (20 CST)
POLYOXYL 20 CETOSTEARYL ETHER
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
XANTHAN GUM
CYCLOMETHICONE 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13537-387	13537-387-01, 13537-387-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
DICAPRYLYL CARBONATE	609A3V1SUA	IACT
PHENETHYL BENZOATE	0C143929GK	IACT
ARGININE	94ZLA3W45F	IACT
CYCLOMETHICONE 6	XHK3U310BA	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
POTASSIUM CETYL PHOSPHATE	03KCY6P7UT	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES	0K5Y9U1P6M	IACT
METHICONE (20 CST)	6777U11MKT	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
1,2-HEXANEDIOL	TR046Y3K1G	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
XANTHAN GUM	TTV12P4NEE	IACT
CYCLOMETHICONE 5	0THT5PCI0R	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 3 · 140 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	GEL / TOPICAL	2 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		6240 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 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
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUSPENSION / TOPICAL	2.15 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	CREAM, AUGMENTED / TOPICAL		260 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	TABLET / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 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
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 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
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	TABLET / ORAL		50 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 11 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	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	TABLET, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 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, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL, FOAM / TOPICAL		374 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 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
339e6660-b8c5-1616-e063-6294a90aba75			0fabcf28-3441-416c-a6b3-82a3f6705c67	2025-04-25	Warnings	Exact identifier spl set id: 0fabcf28-3441-416c-a6b3-82a3f6705c67

Reported adverse events (FAERS/openFDA)#

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