Prep and Prime SPF Mini Set

Product NDC: 82384-0005
Requested package NDC: 82384-0005-1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	82384-0005	82384-0005-1	I	Inactivated by FDA		2026-10-05

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82384-0005-1	2023-01-30	C162847	48780-1	f386c649-d9ec-0266-e053-dadaa90a7c1a	Prep and Prime SPF Mini Set

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82384-0005-1	Prep and Prime SPF Mini Set	1 in 1 KIT	KIT	1		3
82384-0006-1	Prep and Prime SPF Mini Set	10 mL in 1 TUBE	LOTION	10 mL	17.5 g in 100mL	3
82384-0007-1	Prep and Prime SPF Mini Set	10 mL in 1 TUBE	CREAM	10 mL	5 g in 100mL	3
82384-0008-1	Prep and Prime SPF Mini Set	10 mL in 1 BOTTLE	CREAM	10 mL	3 g in 100mL	3
82384-0009-1	Prep and Prime SPF Mini Set	10 mL in 1 BOTTLE	LOTION	10 mL	13 g in 100mL	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82384-0005	PREP AND PRIME SPF MINI SET (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) KIT [SYSTEM BEAUTY, LLC]	3	Legacy NDC, 5 package rows	20211207_d28263a9-e694-662a-e053-2995a90accf1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82384-0005-1	82384000501	1 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 kit	2021-09-27	0000-00-00	No	No	Current