Leader

Product NDC
37205-726
11-digit product format
372050726
Labeler code
37205
Product ID
37205-726_d56a7dfc-78d5-4022-e053-2995a90acb50
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Cardinal Health
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-01-15
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE
Active strength
100 mg/mL; 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 productproduct37205-726DDiscontinued by firm2026-10-05
excluded packagepackage37205-72637205-726-30DDiscontinued 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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37205-726-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-726-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-726-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-726-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-726-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-726-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-726-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-726-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-726-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-726-30ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
HOMOSALATEACTIVE MOIETYV06SV4M95SLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OCTISALATEACTIVE MOIETY4X49Y0596WLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
DIETHYLHEXYL SYRINGYLIDENEMALONATEINACTIVE INGREDIENT3V5U97P248LEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7ULEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
STEAROXYTRIMETHYLSILANEINACTIVE INGREDIENT9862TW94B2LEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8LEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCLEADER SPORT SPF 30 (HOMOSALATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37205-726-3037205072630177 mL in 1 CAN (37205-726-30) 177 ml2012-01-150000-00-00NoNoCurrent