Era Organics Mineral Based SPF 15

Product NDC
72400-752
Requested package NDC
72400-752-02
11-digit product format
724000752
Labeler code
72400
Product ID
72400-752_723771a2-3e8c-e6f3-e053-2a91aa0a4d21
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Era Organics, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-09-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
35 mg/mL; mg/mL
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 packagepackage72400-75272400-752-02IInactivated by FDA2026-10-05

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 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
72400-752-022023-01-30C16284748780-1f386c649-a21e-0266-e053-dadaa90a7c1aEra Organics Mineral Based SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72400-752-02Era Organics Mineral Based SPF 1559 mL in 1 BOTTLE, PUMPCREAM591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72400-752ERA ORGANICS MINERAL BASED SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ERA ORGANICS, INC.]1Legacy NDC, 1 package rows20180901_e5f8c1cf-2c1d-4b81-b730-767e77e1d740.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72400-752-027240007520259 mL in 1 BOTTLE, PUMP (72400-752-02) 59 ml2018-09-010000-00-00NoNoCurrent