FDA.reportPublic FDA data

Leader

Product NDC
70000-0257
Requested package NDC
70000-0257-1
11-digit product format
700000257
Labeler code
70000
Product ID
70000-0257_ecb062bc-15d8-ea4f-e053-2995a90a9927
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
CARDINAL HEALTH, INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-11-22
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-025770000-0257-1DDiscontinued 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 · 1 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 packagepackage70000-025770000-0257-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0257-1ML - Milliliter70000-0257c260da00-1f5c-4775-8e39-9051b9100a5312020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0257LEADER SPORT SUNSCREEN SPF 50 MOISTURIZING (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CARDINAL HEALTH, INC.]4Legacy NDC20241024_97f43ca8-adb0-4b9c-e053-2a95a90aee10.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0257-170000025701237 mL in 1 BOTTLE (70000-0257-1) 237 ml2019-11-220000-00-00NoNoCurrent