FDA.reportPublic FDA data

Sunscreen

Product NDC
59450-978
11-digit product format
594500978
Labeler code
59450
Product ID
59450-978_16529385-b8e5-4215-b7b2-98beecf00ad6
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate,Otisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
The Kroger Co
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-12-06
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
90 mg/mL; mg/mL; mg/mL; mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59450-978DDiscontinued by firm2026-08-03
excluded packagepackage59450-97859450-978-21DDiscontinued by firm2026-08-03

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 productproduct59450-978DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59450-97859450-978-21DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-978SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [THE KROGER CO]9Legacy NDC20250313_e47872ad-01a4-45f0-9399-4f7abc4e5ca3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59450-978-1459450097814156 mL in 1 BOTTLE, PLASTIC (59450-978-14) 156 ml2021-12-060000-00-00NoNoCurrent
59450-978-215945009782188 mL in 1 BOTTLE, PLASTIC (59450-978-21) 88 ml2021-12-060000-00-00NoNoCurrent