Home NDC 58443-0050-4 Panama Jack
Product NDC 58443-0050
Requested package NDC 58443-0050-4
11-digit product format 584430050
Labeler code 58443
Product ID 58443-0050_9c5a1bf7-5baa-67b8-e053-2a95a90a903c
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, and Oxybenzone
Dosage form SPRAY
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-02-18
Marketing end 0000-00-00
Substance OCTINOXATE; OXYBENZONE
Active strength 20 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 3-BUTYLPHTHALIDE INACTIVE INGREDIENT 822Q956KGM PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 7K68DGG29P PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 CARAMEL INACTIVE INGREDIENT T9D99G2B1R PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 MARINE COLLAGEN, SOLUBLE INACTIVE INGREDIENT 8JC99XGU4W PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 OLETH-10 INACTIVE INGREDIENT JD797EF70J PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) INACTIVE INGREDIENT 5041RX63GN PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PANAMA JACK SPF 8 (OCTINOXATE, 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 58443-0050-4 58443005004 237 mL in 1 BOTTLE (58443-0050-4) 237 ml 2013-02-18 0000-00-00 No No Current