CYZONE

Product NDC: 13537-126
11-digit product format: 135370126
Labeler code: 13537
Product ID: 13537-126_c789fd9b-5e71-480f-bb54-8bd33bef1c4b
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate and Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Ventura Corporation Ltd.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-12-13
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 0 g/g; g/g
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	13537-126		D	Discontinued by firm		2026-10-12
excluded package	package	13537-126	13537-126-01	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13537-126-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13537-126-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13537-126-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13537-126-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13537-126-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13537-126-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13537-126-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13537-126-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13537-126-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13537-126-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13537-126-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13537-126-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13537-126-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13537-126-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13537-126-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	13537-126-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	13537-126-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	13537-126-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	13537-126-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	13537-126-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	13537-126-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	13537-126-01	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-126-01	2025-04-04	C162847	48780-1	97449f38-b570-f6ea-e053-dbdaa90aa703	cy°zone cover mat
13537-126-01	2019-11-13	C162847	48780-1	97449f38-b570-f6ea-e053-dbdaa90aa703	cy°zone cover mat

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
BAMBUSA ARUNDINACEA STEM	INACTIVE INGREDIENT	NRA4497HC5	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
IMPERATA CYLINDRICA ROOT	INACTIVE INGREDIENT	VYT2JA85NH	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
PROPYLENE CARBONATE	INACTIVE INGREDIENT	8D08K3S51E	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
SILICA DIMETHYL SILYLATE	INACTIVE INGREDIENT	EU2PSP0G0W	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CYZONE CY COVER MAT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [VENTURA CORPORATION LTD.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
cy°zone cover mat	Ventura Corporation Ltd. \| Bel Star, S. A.(Colombia) \| Yobel Supply Chain Management (Peru)	2011-11-29	HUMAN OTC DRUG LABEL	1

CYZONE

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#