Leader

Product NDC
37205-730
11-digit product format
372050730
Labeler code
37205
Product ID
37205-730_5be4dce8-c477-43cb-ad3f-2e7243e6d69e
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Oxybenzone, 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; OXYBENZONE; AVOBENZONE
Active strength
87 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct37205-730DDiscontinued by firm2026-10-12
excluded packagepackage37205-73037205-730-30DDiscontinued by firm2026-10-12

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 · 24 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 packagepackage37205-730-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-730-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-730-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-730-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-730-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-730-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-730-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-730-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-730-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-730-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-730-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-730-30557ba5c1ecfa…9c80585c8c6e…

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 GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
HOMOSALATEACTIVE MOIETYV06SV4M95SLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OCTISALATEACTIVE MOIETY4X49Y0596WLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8LEADER GP SPF 15 CS (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]1