Sunscreen

Product NDC
37808-726
Requested package NDC
37808-726-10
11-digit product format
378080726
Labeler code
37808
Product ID
37808-726_88331672-bf21-4a69-b082-c8be601d4298
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, zinc oxide
Dosage form
GEL
Route
TOPICAL
Labeler
HEB
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-06-06
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
562 g/g; g/g; g/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 packagepackage37808-72637808-726-10DDiscontinued by firm2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37808-72637808-726-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-72637808-726-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-726SUNSCREEN (OCTINOXATE, OCTISALATE, ZINC OXIDE) GEL [HEB]16Legacy NDC20241024_858ac80c-a0e5-4f0a-aa9f-62698fb29f58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-726-103780807261028.3 g in 1 PACKAGE (37808-726-10) 28.3 g2017-06-060000-00-00NoNoCurrent