Panama Jack

Product NDC: 58443-0201
11-digit product format: 584430201
Labeler code: 58443
Product ID: 58443-0201_9c5a32d8-7794-6786-e053-2a95a90ad52c
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate
Dosage form: OIL
Route: TOPICAL
Labeler: Prime Enterprises Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-12-15
Marketing end: 0000-00-00
Substance: OCTINOXATE
Active strength: 2 g/100g
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58443-0201		I	Inactivated by FDA		2026-10-05
excluded package	package	58443-0201	58443-0201-4	I	Inactivated by FDA		2026-10-05

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 1 · 30 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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`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	58443-0201-4	`1332a3947898…`	`d4bfe170f9cd…`

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
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58443-0201-4	2023-01-30	C162847	48780-1	f386c649-b4de-0266-e053-dadaa90a7c1a	Panama Jack SPF 4 Dark Tanning Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58443-0201-4	Panama JackSPF 4 Dark Tanning Oil	198.7 g in 1 BOTTLE	OIL	198.7		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
LEMON OIL	INACTIVE INGREDIENT	I9GRO824LL	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
PEANUT OIL	INACTIVE INGREDIENT	5TL50QU0W4	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58443-0201	PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]	3	Legacy NDC, 1 package rows	20200118_22b43c46-4cd4-0cbb-e054-00144ff88e88.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58443-0201-4	58443020104	198.7 g in 1 BOTTLE (58443-0201-4)	198.7 g	2011-12-15	0000-00-00	No	No	Current