sunscreen

Product NDC: 19392-400
11-digit product format: 193920400
Labeler code: 19392
Product ID: 19392-400_34817253-7264-43a8-bcaa-1258a75ba993
Type: HUMAN OTC DRUG
Nonproprietary name: octinoxate, octisalate, octocrylene, oxybenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: Humphreyline
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-01-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE
Active strength: 65 mg/g; mg/g; mg/g; mg/g
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	19392-400		I	Inactivated by FDA	2026-10-16
excluded package	package	19392-400	19392-400-03	I	Inactivated by FDA	2026-10-16
excluded package	package	19392-400	19392-400-04	I	Inactivated by FDA	2026-10-16

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	19392-400-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	19392-400-04	`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	19392-400-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	19392-400-04	`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	19392-400-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	19392-400-04	`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	19392-400-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	19392-400-04	`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	19392-400-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	19392-400-04	`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	19392-400-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	19392-400-04	`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	19392-400-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	19392-400-04	`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	19392-400-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	19392-400-04	`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	19392-400-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	19392-400-04	`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	19392-400-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	19392-400-04	`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	19392-400-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	19392-400-04	`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	19392-400-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	19392-400-04	`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	19392-400-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	19392-400-04	`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	19392-400-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	19392-400-04	`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	19392-400-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	19392-400-04	`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	19392-400-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	19392-400-04	`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	19392-400-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	19392-400-04	`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	19392-400-03	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	19392-400-04	`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	19392-400-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	19392-400-04	`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	19392-400-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	19392-400-04	`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
19392-400-03	2019-11-27	C162847	48780-1	9855d018-ee52-cd31-e053-dbdaa90ab51a	Drug Facts
19392-400-04	2019-11-27	C162847	48780-1	9855d018-ee52-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
19392-400-03	sunscreen	28 g in 1 BOTTLE, PLASTIC	LOTION	28		3
19392-400-04	sunscreen	44 g in 1 BOTTLE, PLASTIC	LOTION	44		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
POLYQUATERNIUM-39 (31/40/29 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW)	INACTIVE INGREDIENT	5CO59WNJ6R	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
19392-400	SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]	3	Legacy NDC, 2 package rows	20130503_8863ec8c-5f85-4d07-87de-a407f744012b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
19392-400-03	19392040003	28 g in 1 BOTTLE, PLASTIC	28 g	Historical
19392-400-04	19392040004	44 g in 1 BOTTLE, PLASTIC	44 g	Historical