FDA.reportPublic FDA data

Panama Jack

Product NDC
58443-0179
11-digit product format
584430179
Labeler code
58443
Product ID
58443-0179_9c5a0b7d-ec31-ef9b-e053-2995a90a1824
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Octocrylene, and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-29
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
49 mg/mL; 1/mL; 1/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0179-32023-01-30C16284748780-1f386c649-c4d3-0266-e053-dadaa90a7c1a82c56c45-1f18-418d-946b-d320b9369258

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0179-3Panama Jack30 Broad Spectrum SPF 30 Clear Zinc30 mL in 1 BOTTLELOTION303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMERINACTIVE INGREDIENTCF5W1YCX11PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
DIISODECYL ADIPATEINACTIVE INGREDIENT3V0Q382O0PPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0179PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]3Legacy NDC, 1 package rows20200118_82c56c45-1f18-418d-946b-d320b9369258.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0179-35844301790330 mL in 1 BOTTLE (58443-0179-3) 30 ml2011-12-290000-00-00NoNoCurrent