FDA.reportPublic FDA data

Prep and Prime SPF Mini Set

Product NDC
82384-0005
11-digit product format
823840005
Labeler code
82384
Product ID
82384-0005_d2825e43-c727-559b-e053-2a95a90a019e
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Zinc Oxide
Dosage form
KIT
Route
TOPICAL
Labeler
System Beauty, LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-09-27
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82384-0005-12023-01-30C16284748780-1f386c649-d9ec-0266-e053-dadaa90a7c1aPrep and Prime SPF Mini Set

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82384-0005-1Prep and Prime SPF Mini Set1 in 1 KITKIT13
82384-0006-1Prep and Prime SPF Mini Set10 mL in 1 TUBELOTION10 mL17.5 g in 100mL3
82384-0007-1Prep and Prime SPF Mini Set10 mL in 1 TUBECREAM10 mL5 g in 100mL3
82384-0008-1Prep and Prime SPF Mini Set10 mL in 1 BOTTLECREAM10 mL3 g in 100mL3
82384-0009-1Prep and Prime SPF Mini Set10 mL in 1 BOTTLELOTION10 mL13 g in 100mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82384-0005PREP AND PRIME SPF MINI SET (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) KIT [SYSTEM BEAUTY, LLC]3Legacy NDC, 5 package rows20211207_d28263a9-e694-662a-e053-2995a90accf1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82384-0005-1823840005011 KIT in 1 KIT (82384-0005-1) * 10 mL in 1 TUBE (82384-0007-1) * 10 mL in 1 BOTTLE (82384-0008-1) * 10 mL in 1 BOTTLE (82384-0009-1) * 10 mL in 1 TUBE (82384-0006-1) 1 kit2021-09-270000-00-00NoNoCurrent
82384-0006-18238400060110 mL in 1 TUBE10 mlHistorical
82384-0007-18238400070110 mL in 1 TUBE10 mlHistorical
82384-0008-18238400080110 mL in 1 BOTTLE10 mlHistorical
82384-0009-18238400090110 mL in 1 BOTTLE10 mlHistorical