FDA.reportPublic FDA data

SHISEIDO CLEAR SUNSCREEN SPF 50 Plus

Product NDC
58411-616
11-digit product format
584110616
Labeler code
58411
Product ID
58411-616_e20c68a1-9762-4287-a1e6-001c39639ccf
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
Dosage form
STICK
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
500 mg/20g; mg/20g; mg/20g; mg/20g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58411-616IInactivated by FDA2026-10-12
excluded packagepackage58411-61658411-616-20IInactivated by FDA2026-10-12

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
58411-616-202026-01-29C16284748780-149896155-a59d-586f-e063-e6dba90add90SHISEIDO CLEAR SUNSCREEN STICK SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-616-20SHISEIDO CLEAR SUNSCREEN SPF 50 Plus1 in 1 POUCHSTICK12
58411-616-20SHISEIDO CLEAR SUNSCREEN SPF 50 Plus20 g in 1 CARTRIDGESTICK202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-616SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) STICK [SHISEIDO AMERICAS CORPORATION]2Legacy NDC, 2 package rows20241228_15a786f2-2939-4aa2-a413-b661ff6d2dd9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-616-20584110616201 CARTRIDGE in 1 POUCH (58411-616-20) > 20 g in 1 CARTRIDGE1 cartridge2021-01-010000-00-00NoNoCurrent