FDA.reportPublic FDA data

HARMON FACE VALUES ULTRA SPORT ACTIVE SUNSCREEN SPF 30

Product NDC
63940-084
Requested package NDC
63940-084-48
11-digit product format
639400084
Labeler code
63940
Product ID
63940-084_e4bc9df7-b09e-01fb-e053-2995a90a295d
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
HARMON STORES, INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-03-13
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30 mg/g; mg/g; mg/g; mg/g
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 packagepackage63940-08463940-084-48DDiscontinued by firm2026-10-05

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 · 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 packagepackage63940-08463940-084-48DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63940-08463940-084-48DDiscontinued 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
63940-084HARMON FACE VALUES ULTRA SPORT ACTIVE SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [HARMON STORES, INC.]2Legacy NDC20241023_e4bce775-42d4-724e-e053-2995a90ad3d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63940-084-4863940008448258 g in 1 CAN (63940-084-48) 258 g2008-03-130000-00-00NoNoCurrent