Miami Beach

Product NDC
58443-0260
11-digit product format
584430260
Labeler code
58443
Product ID
58443-0260_9c59f2e3-fc96-4ada-e053-2a95a90acbf4
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-03-27
Marketing end
0000-00-00
Substance
OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE
Active strength
100 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0260-42023-01-30C16284748780-1f386c649-edb7-0266-e053-dadaa90a7c1aMiami Beach Sea Sunscreen Lotion 30 Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0260-4Miami BeachSea Sunscreen Broad Spectrum SPF 30148 mL in 1 TUBELOTION1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0260MIAMI BEACH SEA SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200118_6866cb26-9ec5-1b58-e053-2a91aa0a7b8d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0260-458443026004148 mL in 1 TUBE (58443-0260-4) 148 ml2018-03-270000-00-00NoNoCurrent