CYZONE

Manufacturer: Ventura Corporation Limited | BelStar, S.A.
Effective date: 2010-11-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:51:36

Label at a glance#

ProductCYZONE SUN BY ME

Active ingredientOctinoxate, Oxybenzone, Octisalate, Titanium dioxide

Label structure8 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn. Retains SPF after 40 minutes of activity in the water.

Dosage and administration

Apply liberally 20 minutes before sun exposure and as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients	Purpose
Octinoxate 7.5 %	sunscreen
Octisalate 5.0 %	sunscreen
Oxybenzone 5.0%	sunscreen
Titanium dioxide 0.948%	sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Provides moderate protection against sunburn.
Retains SPF after 40 minutes of activity in the water.

Warnings

WARNINGS SECTION

For external use only.

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 or irritation develops and lasts

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 20 minutes before sun exposure and as needed

Other information

SPL UNCLASSIFIED SECTION

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (water),dicaprylyl carbonate, c12-15 alkyl benzoate, dimethicone, cetearyl alcohol, vp/eicosene copolymer, potassium cetyl phospate, trimethylsiloxysilicate, titanium dioxide, phenoxyethanol, isopropil myristate glyceryl stearate, panthenol, peg-100 stearate, methylparaben, ceteareth-20, xanthan gum, parfum (fragance), propylparaben, propylene glycol, polysorbate 40, ci77019(mica), silica, triethanolamine, methicone, acrylates/c10-30 alkyl acrylate crosspolymer, tetrasodium edta, daucuscarotasativa root extract(daucus carota sativa (carrot) root extract), aloe barbadensis leaf juice, butylparaben, ethylparaben, isobutylparaben, ci 77491(iron oxides), ci 19140 (yellow5), ci 14700 (red4), cocos nucifera (coconut) oil, gardenia tahitensis flower, gardenia tahitensis flower extract ci42090 (blue 1).

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15
FPS
golden bronze

120 ml e (4 fl oz.)

sun
by me

cy°zone

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-110-06	2025-04-01	C162847	48780-1	960f7f55-d448-8e05-e053-dbdaa90a074a	sun by me cy°zone
13537-110-13	2025-04-01	C162847	48780-1	960f7f55-d448-8e05-e053-dbdaa90a074a	sun by me cy°zone
13537-110-06	2019-10-29	C162847	48780-1	960f7f55-d448-8e05-e053-dbdaa90a074a	sun by me cy°zone
13537-110-13	2019-10-29	C162847	48780-1	960f7f55-d448-8e05-e053-dbdaa90a074a	sun by me cy°zone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Titanium dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
Titanium dioxide	ACTIVE MOIETY	15FIX9V2JP	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	1
c12-15 alkyl benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	1
carbomer interpolymer type a (55000 cps)	INACTIVE INGREDIENT	59TL3WG5CO	1
carrot	INACTIVE INGREDIENT	L56Z1JK48B	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
coconut oil	INACTIVE INGREDIENT	Q9L0O73W7L	1
dicaprylyl carbonate	INACTIVE INGREDIENT	609A3V1SUA	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	1
ethylparaben	INACTIVE INGREDIENT	14255EXE39	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C red no. 4	INACTIVE INGREDIENT	X3W0AM1JLX	1
FD&C yellow no. 5	INACTIVE INGREDIENT	I753WB2F1M	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
isobutylparaben	INACTIVE INGREDIENT	0QQJ25X58G	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
polyoxyl 100 stearate	INACTIVE INGREDIENT	YD01N1999R	1
polyoxyl 20 cetostearyl ether	INACTIVE INGREDIENT	YRC528SWUY	1
polysorbate 40	INACTIVE INGREDIENT	STI11B5A2X	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	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 · 37 matching rows.

CYZONE SUN BY ME
Octinoxate, Oxybenzone, Octisalate, and Titanium dioxide
Octinoxate
Oxybenzone
Octisalate
Titanium dioxide
water
dicaprylyl carbonate
c12-15 alkyl benzoate
dimethicone
cetostearyl alcohol
phenoxyethanol
isopropyl myristate
glyceryl monostearate
panthenol
polyoxyl 100 stearate
methylparaben
polyoxyl 20 cetostearyl ether
xanthan gum
propylparaben
propylene glycol
polysorbate 40
mica
silicon dioxide
trolamine
carbomer interpolymer type a (55000 cps)
edetate sodium
carrot
aloe vera leaf
butylparaben
ethylparaben
isobutylparaben
ferric oxide red
FD&C yellow no. 5
FD&C red no. 4
coconut oil
FD&C blue no. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13537-110	13537-110-12, 13537-110-13, 13537-110-05, 13537-110-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Octisalate	4X49Y0596W	ACTIB
Titanium dioxide	15FIX9V2JP	ACTIB
water	059QF0KO0R	IACT
dicaprylyl carbonate	609A3V1SUA	IACT
c12-15 alkyl benzoate	A9EJ3J61HQ	IACT
dimethicone	92RU3N3Y1O	IACT
cetostearyl alcohol	2DMT128M1S	IACT
phenoxyethanol	HIE492ZZ3T	IACT
isopropyl myristate	0RE8K4LNJS	IACT
glyceryl monostearate	230OU9XXE4	IACT
panthenol	WV9CM0O67Z	IACT
polyoxyl 100 stearate	YD01N1999R	IACT
methylparaben	A2I8C7HI9T	IACT
polyoxyl 20 cetostearyl ether	YRC528SWUY	IACT
xanthan gum	TTV12P4NEE	IACT
propylparaben	Z8IX2SC1OH	IACT
propylene glycol	6DC9Q167V3	IACT
polysorbate 40	STI11B5A2X	IACT
mica	V8A1AW0880	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
trolamine	9O3K93S3TK	IACT
carbomer interpolymer type a (55000 cps)	59TL3WG5CO	IACT
edetate sodium	MP1J8420LU	IACT
carrot	L56Z1JK48B	IACT
aloe vera leaf	ZY81Z83H0X	IACT
butylparaben	3QPI1U3FV8	IACT
ethylparaben	14255EXE39	IACT
isobutylparaben	0QQJ25X58G	IACT
ferric oxide red	1K09F3G675	IACT
FD&C yellow no. 5	I753WB2F1M	IACT
FD&C red no. 4	X3W0AM1JLX	IACT
coconut oil	Q9L0O73W7L	IACT
FD&C blue no. 1	H3R47K3TBD	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 9 · 516 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
butylparaben	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	INJECTION, SOLUTION / INTRAVENOUS	0.04 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
polyoxyl 100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 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
xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C yellow no. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 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
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / AURICULAR (OTIC)		36 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL, METERED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		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
butylparaben	BUTYLPARABEN	3QPI1U3FV8	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 15 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	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAMUSCULAR	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C yellow no. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		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	LIQUID / ORAL		162 mg	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	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 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	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
29f0150d-79e4-4d74-862e-352c0057e84d			b12a53cd-0c00-4acd-aad7-afb5ab6ffc23	2010-11-08	Warnings	Exact identifier spl id: 29f0150d-79e4-4d74-862e-352c0057e84d spl set id: b12a53cd-0c00-4acd-aad7-afb5ab6ffc23

Reported adverse events (FAERS/openFDA)#

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