FDA.reportPublic FDA data

Sun Bum Tinted Lip Balm Raisin Hell

Product NDC
69039-265
Requested package NDC
69039-265-00
11-digit product format
690390265
Labeler code
69039
Product ID
69039-265_89a94550-cfe5-6102-e053-2a95a90afe14
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
Sun Bum, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-04-01
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69039-26569039-265-00DDiscontinued by firm2026-10-12

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-265-002022-02-06C16284748780-1d6a99b39-b907-a426-e053-dadaa90af4c2Sun Bum Tinted Lip Balm Raisin Hell
69039-265-002022-01-28C16284748780-1d6a99b39-b907-a426-e053-dadaa90af4c2Sun Bum Tinted Lip Balm Raisin Hell

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69039-265-00690390265004.25 g in 1 TUBE (69039-265-00) 4.25 g2019-04-010000-00-00NoNoCurrent