CYZONE

Manufacturer: Ventura Corporation LTD. | Bel Star S.A. (Colombia) | Yobel Supply Chain Management S.A.
Effective date: 2012-08-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:45:39

Label at a glance#

ProductCYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO

Active ingredientOctinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, Ensulizole

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

Ingredientes activos

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.5%, OCTOCRYLENE 7.0%, OXYBENZONE 6.0%, OCTISALATE 5.0%, TITANIUM DIOXIDE 4.68%, ENSULIZOLE 3.0%

Propósito

OTC - PURPOSE SECTION

Protector solar

Usos

INDICATIONS & USAGE SECTION

Ayuda a prevenir quemaduras solares.
Si se usa según las indicaciones con otras medidas de protección (ver Instrucciones), disminuye el riesgo de cancer en la piel y el envejecimiento prematuro causados por el sol.

Advertencias

WARNINGS SECTION

OTC - DO NOT USE SECTION

Sólo para uso externo.
No usar en piel dañada o lastimada.

OTC - WHEN USING SECTION

Cuando use este producto mantenerlo 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:
- Después de 40 minutos de nadar o sudar.
- Inmediatamente despues de secarse con toalla
- Al menos cada 2 horas.
Niños menores a 6 meses de edad: Consulte al médico
Medidas de protección solar. Pasar tiempo en el sol incrementa su riesgo de cancer en la piel y envejecimiento prematuro. Para disminuir este riesgo, regularmente use un protector solar con un valor de Amplio Espectro FPS de 15 o mas alto y otras medidas de protección inclueyendo:
- Limitar el tiempo en el sol, especialmente de 10 a.m - 2 p.m.
- Vestir camisas de manga larga, pantalones, sombreros y gafas de sol.

Otra información

STORAGE AND HANDLING SECTION

Proteja el producto del calor excesivo y del sol directo.

Ingredientes inactivos

INACTIVE INGREDIENT SECTION

AQUA (WATER), DICAPRYLYL CARBONATE, PHENETHYL BENZOATE, STEARYL DIMETHICONE, DIMETHICONE, ARGININE, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, METHYL METHACRYLATE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, SORBITAN STEARATE, POTASSIUM CETYL PHOSPHATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, SILICA, METHICONE, METHYLPARABEN, ACRYLATES COPOLYMER, CETEARETH-20, PROPYLPARABEN, XANTHAN GUM, PARFUM (FRAGRANCE), BUTYLENE GLYCOL, BUTYLPARABEN, ETHYLPARABEN, ISOBUTYLPARABEN, LITCHI CHINENSIS PERICARP EXTRACT.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 60 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 FPS
amplio espectro
face screen

Protector solar facial
FPS 50 de uso diario
Resistente al agua
(40 minutos)

60 g e (2.1 oz.)

sun
by me

cy°zone

PRINCIPAL DISPLAY PANEL - 60 g Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-435-01	2025-04-24	C162847	48780-1	97449f38-b90f-f6ea-e053-dbdaa90aa703	CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO
13537-435-01	2019-11-13	C162847	48780-1	97449f38-b90f-f6ea-e053-dbdaa90aa703	CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO

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
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
arginine	INACTIVE INGREDIENT	94ZLA3W45F	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	1
dicaprylyl carbonate	INACTIVE INGREDIENT	609A3V1SUA	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
ethylparaben	INACTIVE INGREDIENT	14255EXE39	1
isobutylparaben	INACTIVE INGREDIENT	0QQJ25X58G	1
litchi fruit	INACTIVE INGREDIENT	Y5P61KP51E	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.

CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO
Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, and Ensulizole
Octinoxate
Octocrylene
Oxybenzone
Octisalate
Titanium Dioxide
Ensulizole
water
dicaprylyl carbonate
phenethyl benzoate
dimethicone
arginine
cyclomethicone 5
cetostearyl alcohol
sorbitan monostearate
potassium cetyl phosphate
.alpha.-tocopherol acetate
phenoxyethanol
silicon dioxide
methylparaben
polyoxyl 20 cetostearyl ether
propylparaben
xanthan gum
butylene glycol
butylparaben
ethylparaben
isobutylparaben
litchi fruit

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13537-435	13537-435-01

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
Octinoxate	4Y5P7MUD51	ACTIB
Octocrylene	5A68WGF6WM	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Octisalate	4X49Y0596W	ACTIB
Titanium Dioxide	15FIX9V2JP	ACTIB
Ensulizole	9YQ9DI1W42	ACTIB
water	059QF0KO0R	IACT
dicaprylyl carbonate	609A3V1SUA	IACT
phenethyl benzoate	0C143929GK	IACT
dimethicone	92RU3N3Y1O	IACT
arginine	94ZLA3W45F	IACT
cyclomethicone 5	0THT5PCI0R	IACT
cetostearyl alcohol	2DMT128M1S	IACT
sorbitan monostearate	NVZ4I0H58X	IACT
potassium cetyl phosphate	03KCY6P7UT	IACT
.alpha.-tocopherol acetate	9E8X80D2L0	IACT
phenoxyethanol	HIE492ZZ3T	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
methylparaben	A2I8C7HI9T	IACT
polyoxyl 20 cetostearyl ether	YRC528SWUY	IACT
propylparaben	Z8IX2SC1OH	IACT
xanthan gum	TTV12P4NEE	IACT
butylene glycol	3XUS85K0RA	IACT
butylparaben	3QPI1U3FV8	IACT
ethylparaben	14255EXE39	IACT
isobutylparaben	0QQJ25X58G	IACT
litchi fruit	Y5P61KP51E	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 5 · 296 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	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
arginine	ARGININE	94ZLA3W45F	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 11 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
arginine	ARGININE	94ZLA3W45F	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ethylparaben	ETHYLPARABEN	14255EXE39	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 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
methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUSPENSION / ORAL	62.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 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
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		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
arginine	ARGININE	94ZLA3W45F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		6240 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SPRAY / TOPICAL	4.58 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	OINTMENT / TOPICAL	NA		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
polyoxyl 20 cetostearyl ether	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	SPRAY / TOPICAL	2.42 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 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
338b9c3c-9f17-caef-e063-6394a90ae2f0			63a6e36f-8c13-4a39-999b-b7c0ab8648b2	2025-04-24	Warnings	Exact identifier spl set id: 63a6e36f-8c13-4a39-999b-b7c0ab8648b2

Reported adverse events (FAERS/openFDA)#

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