FDA.reportPublic FDA data

Exuviance Professional OptiLight All-Over Dark Spot Minimizer

Product NDC
58414-0022
Requested package NDC
58414-0022-1
11-digit product format
584140022
Labeler code
58414
Product ID
58414-0022_7b26c473-ab80-4a30-9cb0-78f00a403762
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, and Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
NeoStrata Company Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-06-01
Marketing end
2022-08-13
Substance
OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength
75 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage58414-002258414-0022-1DDiscontinued 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58414-0022-12021-09-22C16284748780-1ba0f9c33-39c6-a910-e053-dadaa90a0b85Exuviance ® OptiLight All-Over Dark Spot Minimizer with Sunsreen Broad Spectrum SPF 35
58414-0022-12021-01-29C16284748780-1ba0f9c33-39c6-a910-e053-dadaa90a0b85Exuviance ® OptiLight All-Over Dark Spot Minimizer with Sunsreen Broad Spectrum SPF 35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58414-0022-1584140022011 TUBE in 1 CARTON (58414-0022-1) > 40 g in 1 TUBE1 tube2019-06-012022-08-13NoNoCurrent