Cyzone

Manufacturer: Ventura Corporation Ltd | Bel Star S.A. (Colombia)
Effective date: 2012-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:49:44

Label at a glance#

ProductCyzone SUN BY ME Sunblock SPF 50

Active ingredientOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE

Label structure9 sections

Indications and uses

Helps prevent sunburn. Provides high protection against sunburn. Retains SPF after 40 minutes of activity in the water.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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
Octocrylene 7.0%	Sunscreen
Oxybenzone 6.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Titanium Dioxide 4.68%	Sunscreen
Ensulizole 3.0%	Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.
Provides high protection against sunburn.
Retains SPF after 40 minutes of activity in the water.

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.

SPL UNCLASSIFIED 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

OTC - ASK DOCTOR 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:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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, 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, 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 Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 FPS
faceblock

60 g e (2.1 oz.)

sun
by me

cy°zone

PRINCIPAL DISPLAY PANEL - 60 g Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-155-01	2025-04-30	C162847	48780-1	97449f38-cfb9-f6ea-e053-dbdaa90aa703	Cyzone SUN BY ME Sunblock SPF 50
13537-155-01	2019-11-13	C162847	48780-1	97449f38-cfb9-f6ea-e053-dbdaa90aa703	Cyzone SUN BY ME Sunblock 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
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 Sunblock SPF 50
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
13537-155	13537-155-01

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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		6240 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 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
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SYRUP / ORAL	28.4 mg/1ml		Exact identifier — unii candidate 15 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	CREAM / TOPICAL		177 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 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
ARGININE	ARGININE	94ZLA3W45F	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 11 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
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 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	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	TABLET, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	INJECTION, SOLUTION / INTRAVENOUS	0.29 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	OINTMENT / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	LOTION / TOPICAL		71 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		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
3400f5f0-4b50-c751-e063-6394a90af083			e11e6141-5386-4fdd-a1b8-49c0c7355a72	2025-04-30	Warnings	Exact identifier spl set id: e11e6141-5386-4fdd-a1b8-49c0c7355a72

Reported adverse events (FAERS/openFDA)#

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