Home NDC 58443-0047 Panama Jack
Product NDC 58443-0047
11-digit product format 584430047
Labeler code 58443
Product ID 58443-0047_9c5a50b7-e1f4-1936-e053-2995a90a6d33
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form SPRAY
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-05-17
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 20 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 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 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 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 58443-0047-4 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 3-BUTYLPHTHALIDE INACTIVE INGREDIENT 822Q956KGM PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 7K68DGG29P PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 BUTYLOCTYL SALICYLATE INACTIVE INGREDIENT 2EH13UN8D3 PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 MARINE COLLAGEN, SOLUBLE INACTIVE INGREDIENT 8JC99XGU4W PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OLETH-10 INACTIVE INGREDIENT JD797EF70J PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PANAMA JACK SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0047-4 58443004704 237 mL in 1 BOTTLE (58443-0047-4) 237 ml 2013-05-17 0000-00-00 No No Current