Miami Beach

Product NDC
58443-0256
11-digit product format
584430256
Labeler code
58443
Product ID
58443-0256_9c59ea17-cd7e-7ccb-e053-2995a90ada4c
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
2017-02-15
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active strength
30 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
58443-0256-42023-01-30C16284748780-1f386c649-d7ff-0266-e053-dadaa90a7c1aMiami Beach Kids Sunscreen Lotion Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0256-4Miami BeachKids Sunscreen Broad Spectrum SPF 50177 mL in 1 BOTTLELOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0256MIAMI BEACH KIDS SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200118_678b9575-3271-9c42-e053-2a91aa0a5c91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0256-458443025604177 mL in 1 BOTTLE (58443-0256-4) 177 ml2017-02-150000-00-00NoNoCurrent