Sunscreen

Product NDC: 75887-003
11-digit product format: 758870003
Labeler code: 75887
Product ID: 75887-003_1a05b791-a0ae-48b3-a951-b6928d0bfa44
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OXYBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: Aztex Enterprises
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-01-18
Marketing end: 0000-00-00
Substance: OCTINOXATE; OXYBENZONE
Active strength: 22 mL/30mL; mL/30mL
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	75887-003		I	Inactivated by FDA	2026-10-21
excluded package	package	75887-003	75887-003-01	I	Inactivated by FDA	2026-10-21
excluded package	package	75887-003	75887-003-02	I	Inactivated by FDA	2026-10-21
excluded package	package	75887-003	75887-003-03	I	Inactivated by FDA	2026-10-21
excluded package	package	75887-003	75887-003-04	I	Inactivated by FDA	2026-10-21

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	75887-003-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75887-003-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75887-003-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75887-003-04	`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	75887-003-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75887-003-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75887-003-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75887-003-04	`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	75887-003-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75887-003-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75887-003-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75887-003-04	`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	75887-003-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75887-003-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75887-003-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75887-003-04	`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	75887-003-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75887-003-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75887-003-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75887-003-04	`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	75887-003-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75887-003-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75887-003-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75887-003-04	`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	75887-003-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75887-003-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75887-003-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75887-003-04	`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	75887-003-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75887-003-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75887-003-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75887-003-04	`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	75887-003-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75887-003-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75887-003-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75887-003-04	`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	75887-003-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75887-003-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75887-003-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75887-003-04	`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	75887-003-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75887-003-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75887-003-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75887-003-04	`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	75887-003-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75887-003-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75887-003-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75887-003-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
75887-003-01	1bf464b3-f9ac-4c7e-9ec9-7a9b7e97f2e9
75887-003-02	1bf464b3-f9ac-4c7e-9ec9-7a9b7e97f2e9
75887-003-03	1bf464b3-f9ac-4c7e-9ec9-7a9b7e97f2e9
75887-003-04	1bf464b3-f9ac-4c7e-9ec9-7a9b7e97f2e9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75887-003-01	Sunscreen30 SPF	30 mL in 1 BOTTLE	LOTION	30	3
75887-003-02	Sunscreen30 SPF	60 mL in 1 BOTTLE	LOTION	60	3
75887-003-03	Sunscreen30 SPF	118 mL in 1 BOTTLE	LOTION	118	3
75887-003-04	Sunscreen30 SPF	236 mL in 1 BOTTLE	LOTION	236	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	INACTIVE INGREDIENT	59TL3WG5CO	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3
UREA	INACTIVE INGREDIENT	8W8T17847W	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75887-003	SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]	3	Legacy NDC, 4 package rows	20110119_1bf464b3-f9ac-4c7e-9ec9-7a9b7e97f2e9.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
75887-003-01	75887000301	30 mL in 1 BOTTLE	30 ml	Historical
75887-003-02	75887000302	60 mL in 1 BOTTLE	60 ml	Historical
75887-003-03	75887000303	118 mL in 1 BOTTLE	118 ml	Historical
75887-003-04	75887000304	236 mL in 1 BOTTLE	236 ml	Historical