FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-890
Requested package NDC
63354-890-57
11-digit product format
633540890
Labeler code
63354
Product ID
63354-890_b634560b-3e26-0c79-e053-2995a90a8248
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE HOMOSALATE OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-02-23
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
2 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage63354-89063354-890-57DDiscontinued by firm2026-10-05

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 · 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, Related label table
NDCEffectiveRelated label
63354-890-012023-11-250fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-212023-11-250fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-222023-11-250fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-562023-11-250fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-572023-11-250fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-012023-01-300fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-212023-01-300fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-222023-01-300fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-562023-01-300fc6cad0-13e5-6aa9-e054-00144ff8d46c
63354-890-572023-01-300fc6cad0-13e5-6aa9-e054-00144ff8d46c

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-890-5763354089057295 g in 1 BOTTLE (63354-890-57) 295 g2015-02-230000-00-00NoNoCurrent