Panama Jack

Product NDC
13630-0036
Requested package NDC
13630-0036-4
11-digit product format
136300036
Labeler code
13630
Product ID
13630-0036_9c5be6dd-2780-299e-e053-2995a90ada84
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-02-21
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
26 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13630-003613630-0036-4IInactivated by FDA2026-10-05

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0036-42024-01-30C16284748780-11030e365-4c75-111a-e063-dadaa90a10e28e8f707b-734c-4bd3-bac5-951f647f37b9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0036-4Panama JackBroad Spectrum SPF 70177 mL in 1 CANSPRAY1773

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PPANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0036PANAMA JACK BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]3Legacy NDC, 1 package rows20200118_8e8f707b-734c-4bd3-bac5-951f647f37b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0036-413630003604177 mL in 1 CAN (13630-0036-4) 177 ml2012-02-210000-00-00NoNoCurrent