FDA.reportPublic FDA data

EXTREME

Product NDC
60289-285
Requested package NDC
60289-285-24
11-digit product format
602890285
Labeler code
60289
Product ID
60289-285_63351dc1-a7b2-418b-b6b5-19342a28b28e
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Avobenzone, Ensulizole, and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
AHAVA Dead Sea Laboratories Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-05-15
Marketing end
0000-00-00
Substance
AVOBENZONE; ENSULIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage60289-28560289-285-24DDiscontinued by firm2026-10-15

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 · 9 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…

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
60289-285-242023-11-08C16284748780-10191ceaa-6130-198a-e063-dbdaa90aec3eEXTREME AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30
60289-285-242023-07-28C16284748780-10191ceaa-6130-198a-e063-dbdaa90aec3eEXTREME AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60289-285-24602890285241 BOTTLE, GLASS in 1 CARTON (60289-285-24) > 50 mL in 1 BOTTLE, GLASS2019-05-150000-00-00NoNoCurrent