Anew Vitale

Product NDC: 10096-0319
11-digit product format: 100960319
Labeler code: 10096
Product ID: 10096-0319_8695e3ec-61a6-f2e4-e053-2a91aa0a15b0
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octisalate, Oxybenzone, Avobenzone
Dosage form: CREAM
Route: TOPICAL
Labeler: New Avon LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-03-17
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength: 70 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	10096-0319		I	Inactivated by FDA	2026-09-14
excluded package	package	10096-0319	10096-0319-2	I	Inactivated by FDA	2026-09-14
excluded package	package	10096-0319	10096-0319-4	I	Inactivated by FDA	2026-09-14
excluded package	package	10096-0319	10096-0319-5	I	Inactivated by FDA	2026-09-14

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 · 76 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	10096-0319-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10096-0319-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10096-0319-5	`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	10096-0319-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10096-0319-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10096-0319-5	`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	10096-0319-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10096-0319-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10096-0319-5	`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	10096-0319-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10096-0319-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10096-0319-5	`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	10096-0319-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10096-0319-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10096-0319-5	`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	10096-0319-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10096-0319-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10096-0319-5	`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	10096-0319-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10096-0319-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10096-0319-5	`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	10096-0319-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10096-0319-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10096-0319-5	`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	10096-0319-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10096-0319-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10096-0319-5	`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	10096-0319-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10096-0319-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10096-0319-5	`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	10096-0319-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10096-0319-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10096-0319-5	`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	10096-0319-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10096-0319-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10096-0319-5	`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	10096-0319-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10096-0319-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10096-0319-5	`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	10096-0319-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10096-0319-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10096-0319-5	`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	10096-0319-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10096-0319-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10096-0319-5	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10096-0319-2	2021-01-29	C162847	48780-1	ba0f9c33-585f-a910-e053-dadaa90a0b85	Anew Vitale Day Cream Broad Spectrum SPF 25
10096-0319-4	2021-01-29	C162847	48780-1	ba0f9c33-585f-a910-e053-dadaa90a0b85	Anew Vitale Day Cream Broad Spectrum SPF 25
10096-0319-5	2021-01-29	C162847	48780-1	ba0f9c33-585f-a910-e053-dadaa90a0b85	Anew Vitale Day Cream Broad Spectrum SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10096-0319-1	Anew VitaleDay	50 g in 1 JAR	CREAM	50	5
10096-0319-2	Anew VitaleDay	1 in 1 CARTON	CREAM	1	5
10096-0319-3	Anew VitaleDay	15 g in 1 JAR	CREAM	15	5
10096-0319-4	Anew VitaleDay	1 in 1 CARTON	CREAM	1	5
10096-0319-5	Anew VitaleDay	1.1 g in 1 PACKET	CREAM	1.1	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10096-0319	ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [NEW AVON LLC]	5	Legacy NDC, 5 package rows	20190416_9f8ef748-fc61-4f49-909f-93fed9c8a08a.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
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
10096-0319-1	10096031901	50 g in 1 JAR	50 g	Historical
10096-0319-2	10096031902	1 in 1 CARTON		Historical
10096-0319-3	10096031903	15 g in 1 JAR	15 g	Historical
10096-0319-4	10096031904	1 in 1 CARTON		Historical
10096-0319-5	10096031905	1.1 g in 1 PACKET	1.1 g	Historical