Clarant B3

Product NDC: 51769-614
11-digit product format: 517690614
Labeler code: 51769
Product ID: 51769-614_a01e67cc-29df-415d-b742-a6ca74b63604
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone Octinoxate
Dosage form: CREAM
Route: TOPICAL
Labeler: ALL NATURAL DYNAMICS
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-07-04
Marketing end: 0000-00-00
Substance: AVOBENZONE; OCTINOXATE
Active strength: 2800 mg/100g; mg/100g
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51769-614		I	Inactivated by FDA	2026-08-17
excluded package	package	51769-614	51769-614-05	I	Inactivated by FDA	2026-08-17
excluded package	package	51769-614	51769-614-10	I	Inactivated by FDA	2026-08-17
excluded package	package	51769-614	51769-614-20	I	Inactivated by FDA	2026-08-17
excluded package	package	51769-614	51769-614-40	I	Inactivated by FDA	2026-08-17

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 · 110 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	51769-614-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-614-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-614-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-614-40	`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	51769-614-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-614-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-614-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-614-40	`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	51769-614-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-614-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-614-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-614-40	`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	51769-614-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-614-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-614-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-614-40	`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	51769-614-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-614-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-614-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-614-40	`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	51769-614-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-614-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-614-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-614-40	`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	51769-614-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-614-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-614-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-614-40	`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	51769-614-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51769-614-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51769-614-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51769-614-40	`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	51769-614-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51769-614-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51769-614-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51769-614-40	`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	51769-614-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51769-614-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51769-614-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51769-614-40	`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	51769-614-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51769-614-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51769-614-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51769-614-40	`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	51769-614-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51769-614-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51769-614-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51769-614-40	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51769-614-05	Clarant B3 Normal to Dry Skin
51769-614-10	Clarant B3 Normal to Dry Skin
51769-614-20	Clarant B3 Normal to Dry Skin
51769-614-40	Clarant B3 Normal to Dry Skin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51769-614-05	Clarant B3	50 g in 1 JAR	CREAM	50	1
51769-614-10	Clarant B3	100 g in 1 JAR	CREAM	100	1
51769-614-20	Clarant B3	200 g in 1 JAR	CREAM	200	1
51769-614-40	Clarant B3	400 g in 1 JAR	CREAM	400	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Niacinamide	INACTIVE INGREDIENT	25X51I8RD4	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Sodium Ascorbyl Phosphate	INACTIVE INGREDIENT	836SJG51DR	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51769-614	CLARANT B3 (AVOBENZONE OCTINOXATE) CREAM [ALL NATURAL DYNAMICS]	1	Legacy NDC, 4 package rows	20140717_afa74512-e3d8-49a5-a0dc-dae0cf8a7a00.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51769-614-05	51769061405	50 g in 1 JAR	50 g	Historical
51769-614-10	51769061410	100 g in 1 JAR	100 g	Historical
51769-614-20	51769061420	200 g in 1 JAR	200 g	Historical
51769-614-40	51769061440	400 g in 1 JAR	400 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarant B3 Normal to Dry Skin	ALL NATURAL DYNAMICS \| Unilever Manufacturera, S. de R.L. de C.V.	2014-07-04	HUMAN OTC DRUG LABEL	1