CYZONE

Product NDC: 13537-110
11-digit product format: 135370110
Labeler code: 13537
Product ID: 13537-110_29f0150d-79e4-4d74-862e-352c0057e84d
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Oxybenzone, Octisalate, and Titanium dioxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Ventura Corporation Limited
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-04-22
Marketing end: 0000-00-00
Substance: OCTINOXATE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE
Active strength: 0 g/mL; g/mL; g/mL; g/mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13537-110		D	Discontinued by firm	2026-10-16
excluded package	package	13537-110	13537-110-06	D	Discontinued by firm	2026-10-16
excluded package	package	13537-110	13537-110-13	D	Discontinued by firm	2026-10-16

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 2 · 66 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	13537-110-06	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13537-110-13	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	13537-110-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	13537-110-13	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	13537-110-06	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	13537-110-13	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
13537-110-06	2025-04-01	sun by me cy°zone
13537-110-13	2025-04-01	sun by me cy°zone
13537-110-06	2019-10-29	sun by me cy°zone
13537-110-13	2019-10-29	sun by me cy°zone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
Titanium dioxide	ACTIVE INGREDIENT	15FIX9V2JP	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
Titanium dioxide	ACTIVE MOIETY	15FIX9V2JP	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
c12-15 alkyl benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
carbomer interpolymer type a (55000 cps)	INACTIVE INGREDIENT	59TL3WG5CO	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
carrot	INACTIVE INGREDIENT	L56Z1JK48B	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
coconut oil	INACTIVE INGREDIENT	Q9L0O73W7L	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
dicaprylyl carbonate	INACTIVE INGREDIENT	609A3V1SUA	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
ethylparaben	INACTIVE INGREDIENT	14255EXE39	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
FD&C red no. 4	INACTIVE INGREDIENT	X3W0AM1JLX	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
FD&C yellow no. 5	INACTIVE INGREDIENT	I753WB2F1M	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
isobutylparaben	INACTIVE INGREDIENT	0QQJ25X58G	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
mica	INACTIVE INGREDIENT	V8A1AW0880	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
polyoxyl 100 stearate	INACTIVE INGREDIENT	YD01N1999R	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
polyoxyl 20 cetostearyl ether	INACTIVE INGREDIENT	YRC528SWUY	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
polysorbate 40	INACTIVE INGREDIENT	STI11B5A2X	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

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#