bioCorneum plus SPF 30 advanced SCAR SUPERVISION

Product NDC: 43474-001
11-digit product format: 434740001
Labeler code: 43474
Product ID: 43474-001_e22951c5-cacf-47cb-9bb3-f722520a33e7
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Dosage form: GEL
Route: TOPICAL
Labeler: Enaltus Inc
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-04-10
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 8 g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	43474-001		I	Inactivated by FDA	2026-08-03
excluded package	package	43474-001	43474-001-10	I	Inactivated by FDA	2026-08-03
excluded package	package	43474-001	43474-001-20	I	Inactivated by FDA	2026-08-03
excluded package	package	43474-001	43474-001-50	I	Inactivated by FDA	2026-08-03

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 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43474-001-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43474-001-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43474-001-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43474-001-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43474-001-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43474-001-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43474-001-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43474-001-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43474-001-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43474-001-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43474-001-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43474-001-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43474-001-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43474-001-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43474-001-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43474-001-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43474-001-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43474-001-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43474-001-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43474-001-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43474-001-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43474-001-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43474-001-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43474-001-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43474-001-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43474-001-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43474-001-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43474-001-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43474-001-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43474-001-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43474-001-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43474-001-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43474-001-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43474-001-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43474-001-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43474-001-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43474-001-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43474-001-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43474-001-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43474-001-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43474-001-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43474-001-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43474-001-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43474-001-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43474-001-10	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43474-001-10	2020-01-31	C162847	48780-1	9d75b9d0-22bd-f424-e053-dadaa90a57ce	bioCorneum + plus SPF 30 advanced SCAR SUPERVISION
43474-001-20	2020-01-31	C162847	48780-1	9d75b9d0-22bd-f424-e053-dadaa90a57ce	bioCorneum + plus SPF 30 advanced SCAR SUPERVISION
43474-001-50	2020-01-31	C162847	48780-1	9d75b9d0-22bd-f424-e053-dadaa90a57ce	bioCorneum + plus SPF 30 advanced SCAR SUPERVISION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43474-001-10	bioCorneum plus SPF 30 advanced SCAR SUPERVISION	10 g in 1 BOTTLE, PUMP	GEL	10	1
43474-001-10	bioCorneum plus SPF 30 advanced SCAR SUPERVISION	1 in 1 CARTON	GEL	1	1
43474-001-20	bioCorneum plus SPF 30 advanced SCAR SUPERVISION	20 g in 1 BOTTLE, PUMP	GEL	20	1
43474-001-20	bioCorneum plus SPF 30 advanced SCAR SUPERVISION	1 in 1 CARTON	GEL	1	1
43474-001-50	bioCorneum plus SPF 30 advanced SCAR SUPERVISION	50 g in 1 BOTTLE, PUMP	GEL	50	1
43474-001-50	bioCorneum plus SPF 30 advanced SCAR SUPERVISION	1 in 1 CARTON	GEL	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43474-001	BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [ENALTUS INC]	1	Legacy NDC, 6 package rows	20140410_f87a0c39-bf55-4547-87b1-2415d72391c9.zip

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
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43474-001-10	43474000110	10 g in 1 BOTTLE, PUMP	10 g	Historical
43474-001-20	43474000120	20 g in 1 BOTTLE, PUMP	20 g	Historical
43474-001-50	43474000150	50 g in 1 BOTTLE, PUMP	50 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
bioCorneum + plus SPF 30 advanced SCAR SUPERVISION	Enaltus Inc \| Formulated Solutions, LLC	2014-04-10	HUMAN OTC DRUG LABEL	1