LBEL

Product NDC: 13537-026
11-digit product format: 135370026
Labeler code: 13537
Product ID: 13537-026_bab857e0-394d-4e26-af70-17e0cac83524
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Ventura Corporation Ltd.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-08-10
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OXYBENZONE; 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13537-026		D	Discontinued by firm	2026-10-05
excluded package	package	13537-026	13537-026-02	D	Discontinued by firm	2026-10-05
excluded package	package	13537-026	13537-026-04	D	Discontinued by firm	2026-10-05
excluded package	package	13537-026	13537-026-06	D	Discontinued by firm	2026-10-05

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 · 88 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	13537-026-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13537-026-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13537-026-06	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	13537-026-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13537-026-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13537-026-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13537-026-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13537-026-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13537-026-06	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13537-026-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13537-026-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13537-026-06	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13537-026-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13537-026-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13537-026-06	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13537-026-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13537-026-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13537-026-06	D	Discontinued by firm	`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	13537-026-02	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13537-026-04	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13537-026-04	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13537-026-04	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13537-026-04	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13537-026-04	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13537-026-04	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13537-026-04	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13537-026-04	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13537-026-06	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	13537-026-02	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13537-026-04	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13537-026-06	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
13537-026-02	2025-02-20	L'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15
13537-026-04	2025-02-20	L'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15
13537-026-06	2025-02-20	L'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15
13537-026-02	2019-10-29	L'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15
13537-026-04	2019-10-29	L'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15
13537-026-06	2019-10-29	L'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
Titanium dioxide	ACTIVE INGREDIENT	15FIX9V2JP	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
Titanium dioxide	ACTIVE MOIETY	15FIX9V2JP	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
alkyl (c12-15) benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
arginine	INACTIVE INGREDIENT	94ZLA3W45F	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
aspartic acid	INACTIVE INGREDIENT	30KYC7MIAI	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
cyclomethicone 6	INACTIVE INGREDIENT	XHK3U310BA	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
dicaprylyl carbonate	INACTIVE INGREDIENT	609A3V1SUA	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
ethylparaben	INACTIVE INGREDIENT	14255EXE39	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
histidine monohydrochloride	INACTIVE INGREDIENT	1D5Q932XM6	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
isobutylparaben	INACTIVE INGREDIENT	0QQJ25X58G	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
khaya senegalensis bark	INACTIVE INGREDIENT	1S7EDA839L	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
nadide	INACTIVE INGREDIENT	0U46U6E8UK	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
pea	INACTIVE INGREDIENT	W4X7H8GYFM	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
polyoxyl 20 cetostearyl ether	INACTIVE INGREDIENT	YRC528SWUY	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
potassium cetyl phosphate	INACTIVE INGREDIENT	03KCY6P7UT	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
pyridoxine hydrochloride	INACTIVE INGREDIENT	68Y4CF58BV	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
sodium succinate anhydrous	INACTIVE INGREDIENT	V8ZGC8ISR3	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1
yeast	INACTIVE INGREDIENT	3NY3SM6B8U	LBEL (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LTD.]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
L'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15	Ventura Corporation Ltd. \| BelStar, S.A.	2011-08-11	HUMAN OTC DRUG LABEL	1

LBEL

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#