Coppertone Sport

Product NDC
11523-7325
Requested package NDC
11523-7325-2
11-digit product format
115237325
Labeler code
11523
Product ID
11523-7325_8f9aa2c5-512d-e084-e053-2995a90a4b75
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1999-05-21
Marketing end
2021-09-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
31 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage11523-732511523-7325-2DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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 INGREDIENTG63QQF2NOXCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
HomosalateACTIVE INGREDIENTV06SV4M95SCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
OctisalateACTIVE INGREDIENT4X49Y0596WCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
OctocryleneACTIVE INGREDIENT5A68WGF6WMCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
OxybenzoneACTIVE INGREDIENT95OOS7VE0YCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
AvobenzoneACTIVE MOIETYG63QQF2NOXCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
HomosalateACTIVE MOIETYV06SV4M95SCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
OctisalateACTIVE MOIETY4X49Y0596WCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
OctocryleneACTIVE MOIETY5A68WGF6WMCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
OxybenzoneACTIVE MOIETY95OOS7VE0YCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
.Alpha.-tocopherolINACTIVE INGREDIENTH4N855PNZ1COPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RACOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
Butyloctyl SalicylateINACTIVE INGREDIENT2EH13UN8D3COPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
Sodium Ascorbyl PhosphateINACTIVE INGREDIENT836SJG51DRCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
TrolamineINACTIVE INGREDIENT9O3K93S3TKCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVCCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RCOPPERTONE SPORT SPF 100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MSD CONSUMER CARE, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7325-21152373250289 mL in 1 BOTTLE, PLASTIC (11523-7325-2) 89 ml2017-11-012021-09-01NoNoCurrent