Sun Protection Emulsion Face

Product NDC: 59614-221
11-digit product format: 596140221
Labeler code: 59614
Product ID: 59614-221_10ada59f-faaf-47e7-b15a-b96e5118ebe1
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, octisalate, octocrylene, oxybenzone
Dosage form: CREAM
Route: TOPICAL
Labeler: Juvena GMBH
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-02-14
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 3 mL/100mL; 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	59614-221		I	Inactivated by FDA	2026-10-20
excluded package	package	59614-221	59614-221-02	I	Inactivated by FDA	2026-10-20
excluded package	package	59614-221	59614-221-11	I	Inactivated by FDA	2026-10-20

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	59614-221-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59614-221-11	`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	59614-221-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59614-221-11	`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	59614-221-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59614-221-11	`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	59614-221-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59614-221-11	`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	59614-221-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59614-221-11	`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	59614-221-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59614-221-11	`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	59614-221-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59614-221-11	`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	59614-221-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59614-221-11	`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	59614-221-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59614-221-11	`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	59614-221-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59614-221-11	`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	59614-221-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59614-221-11	`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	59614-221-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59614-221-11	`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	59614-221-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59614-221-11	`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	59614-221-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59614-221-11	`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	59614-221-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59614-221-11	`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	59614-221-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59614-221-11	`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	59614-221-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59614-221-11	`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	59614-221-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59614-221-11	`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	59614-221-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59614-221-11	`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	59614-221-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59614-221-11	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59614-221-02	2019-10-29	C162847	48780-1	960f7f55-d3b5-8e05-e053-dbdaa90a074a	Sun Protection Emulsion Face SPF 30
59614-221-11	2019-10-29	C162847	48780-1	960f7f55-d3b5-8e05-e053-dbdaa90a074a	Sun Protection Emulsion Face SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59614-221-01	Sun Protection Emulsion Face la prairie	125 mL in 1 BOTTLE	CREAM	125	2
59614-221-02	Sun Protection Emulsion Face la prairie	1 in 1 BOX	CREAM	1	2
59614-221-11	Sun Protection Emulsion Face la prairie	0.088 mL in 1 DRUM	CREAM	0.088	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Homosalate	ACTIVE MOIETY	V06SV4M95S	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
octisalate	ACTIVE MOIETY	4X49Y0596W	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
alcohol	INACTIVE INGREDIENT	3K9958V90M	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
ALUMINUM STARCH OCTENYLSUCCINATE	INACTIVE INGREDIENT	I9PJ0O6294	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
Hexyldecanol	INACTIVE INGREDIENT	151Z7P1317	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
SODIUM LACTATE	INACTIVE INGREDIENT	TU7HW0W0QT	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
squalane	INACTIVE INGREDIENT	GW89575KF9	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59614-221	SUN PROTECTION EMULSION FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ) CREAM [JUVENA GMBH]	2	Legacy NDC, 3 package rows	20110216_688e7583-7e08-44f0-9af5-cec94678da25.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
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
59614-221-01	59614022101	125 mL in 1 BOTTLE	125 ml	Historical
59614-221-02	59614022102	1 in 1 BOX		Historical
59614-221-11	59614022111	0.088 mL in 1 DRUM	0.088 ml	Historical