Sun protection body

Product NDC: 59614-511
11-digit product format: 596140511
Labeler code: 59614
Product ID: 59614-511_b89511ec-8fc8-4c35-8600-320f915312f6
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octislate, Oxybenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: Juvena Produits de Beaute GMBH
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-02-14
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE
Active strength: 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL
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	59614-511		I	Inactivated by FDA	2026-10-15
excluded package	package	59614-511	59614-511-02	I	Inactivated by FDA	2026-10-15
excluded package	package	59614-511	59614-511-11	I	Inactivated by FDA	2026-10-15

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	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	59614-511-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59614-511-02	`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	59614-511-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59614-511-02	`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	59614-511-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59614-511-02	`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	59614-511-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59614-511-02	`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	59614-511-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59614-511-02	`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	59614-511-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59614-511-02	`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	59614-511-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59614-511-02	`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	59614-511-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59614-511-02	`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	59614-511-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59614-511-02	`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	59614-511-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59614-511-02	`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	59614-511-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59614-511-02	`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	59614-511-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59614-511-02	`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	59614-511-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59614-511-02	`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	59614-511-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59614-511-02	`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	59614-511-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59614-511-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59614-511-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59614-511-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59614-511-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59614-511-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59614-511-11	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59614-511-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59614-511-11	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59614-511-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59614-511-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59614-511-02	`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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59614-511-02	2019-10-29	C162847	48780-1	960f7f55-c317-8e05-e053-dbdaa90a074a	Sun Protection Lotion Body SPF 30
59614-511-11	2019-10-29	C162847	48780-1	960f7f55-c317-8e05-e053-dbdaa90a074a	Sun Protection Lotion Body SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59614-511-01	Sun protection body SPF 30	180 mL in 1 BOTTLE	LOTION	180	4
59614-511-02	Sun protection body SPF 30	1 in 1 BOX	LOTION	1	4
59614-511-11	Sun protection body SPF 30	0.09 mL in 1 DRUM	LOTION	0.09	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59614-511	SUN PROTECTION BODY (AVOBENZONE, HOMOSALATE, OCTISLATE, OXYBENZONE ) LOTION [JUVENA PRODUITS DE BEAUTE GMBH]	4	Legacy NDC, 3 package rows	20110216_57d7bd17-1387-4f61-bb41-27f49d3d55b6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
59614-511-01	59614051101	180 mL in 1 BOTTLE	180 ml	Historical
59614-511-02	59614051102	1 in 1 BOX		Historical
59614-511-11	59614051111	0.09 mL in 1 DRUM	0.09 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sun Protection Lotion Body SPF 30	Juvena Produits de Beaute GMBH \| Temmentec Ag	2011-02-14	HUMAN OTC DRUG LABEL	4