Panama Jack

Product NDC
13630-0032
11-digit product format
136300032
Labeler code
13630
Product ID
13630-0032_e77b6aff-0c43-5a2a-e053-2a95a90a8090
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-01-04
Marketing end
2022-12-31
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
17 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13630-0032DDiscontinued by firm2026-10-28
excluded packagepackage13630-003213630-0032-4DDiscontinued by firm2026-10-28

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13630-0032-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13630-0032-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13630-0032-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13630-0032-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13630-0032-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13630-0032-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13630-0032-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13630-0032-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13630-0032-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13630-0032-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13630-0032-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13630-0032-4557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PPANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 206 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orchidee Double Defense Skin ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.74b3c33f-5db5-460d-97be-fa495b6252492025-06-27WarningsExact identifier
application number: M020
GHOSTEDZINC OXIDESpoogea5b611c3-d4d3-461e-84d8-d04a29c749022025-06-26WarningsExact identifier
application number: M020
Dew MeZINC OXIDESpooge0c4b429b-7dd5-4929-95af-d02b6770f1212025-06-26WarningsExact identifier
application number: M020
Zinc FIVE-0 baby and kids mineral sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38744f77-4845-eac4-e063-6294a90af6482025-06-26WarningsExact identifier
application number: M020
NYU Langone Health Lip BalmZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd38745b55-8da5-4627-e063-6394a90a24ca2025-06-26WarningsExact identifier
application number: M020
Active Skin Repair hydrating daily sunscreenZINC OXIDEInnovacyn, Inc.1eacdde1-f990-4962-92f1-3f41a8a3b1932025-06-26WarningsExact identifier
application number: M020
CheekyZINC OXIDESpooged377379a-a1be-4acf-9df5-2ff73fb5c83d2025-06-26WarningsExact identifier
application number: M020
TheOGZINC OXIDESpoogea2f781a8-eba8-48f5-8680-9235aae8a4ff2025-06-26WarningsExact identifier
application number: M020
Reef safe - Vitamin C sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0763-74e9-3a71-e063-6394a90a46fb2025-06-25WarningsExact identifier
application number: M020
Reef safe - acne-prone sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f079c-5730-5111-e063-6394a90af2d82025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Face sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0f79-016f-71a7-e063-6394a90a92862025-06-25WarningsExact identifier
application number: M020
Reef safe - Baby zinc sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f320c-9144-78b8-e063-6394a90a2e9d2025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Sport sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385ff227-1656-960a-e063-6294a90a913c2025-06-25WarningsExact identifier
application number: M020
Thermasun SPF50 Mineral Zinc facial sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ecba0-2f7f-9178-e063-6394a90a44c42025-06-25WarningsExact identifier
application number: M020
Reefsun sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ec055-4ae7-9d2d-e063-6394a90a83c02025-06-25WarningsExact identifier
application number: M020
SR Active Sheer Zinc Face Stick SPF 5020.6% ZINC OXIDESkinresource.md, L.L.C.29928ab0-4467-57cb-e063-6394a90ac4d32025-06-25WarningsExact identifier
application number: M020
Sun Protection SPF 50AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5%Skinresource.md, L.L.C.2a0c3dd1-4bc0-6664-e063-6294a90af4b32025-06-25WarningsExact identifier
application number: M020
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
application number: M020
Blooskim BEEF TALLOW SUNSCREENNON-NANO ZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.384903fa-e739-08b8-e063-6394a90a76532025-06-24WarningsExact identifier
application number: M020
Walgreens SPF 55 Sheer Face Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf05b45e2-2fcd-631e-e053-2995a90ad3342025-06-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0032-413630003204177 mL in 1 CAN (13630-0032-4) 177 ml2012-01-040000-00-00NoNoCurrent