FDA.reportPublic FDA data

Coppertone Wet and Clear Kids

Product NDC
11523-7355
Requested package NDC
11523-7355-2
11-digit product format
115237355
Labeler code
11523
Product ID
11523-7355_9842b69b-0180-0664-e053-2995a90a97c2
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-03-15
Marketing end
2021-09-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
27 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 packagepackage11523-735511523-7355-2DDiscontinued 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 WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
HomosalateACTIVE INGREDIENTV06SV4M95SCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
OctisalateACTIVE INGREDIENT4X49Y0596WCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
OctocryleneACTIVE INGREDIENT5A68WGF6WMCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
OxybenzoneACTIVE INGREDIENT95OOS7VE0YCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
avobenzoneACTIVE MOIETYG63QQF2NOXCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
HomosalateACTIVE MOIETYV06SV4M95SCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
OctisalateACTIVE MOIETY4X49Y0596WCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
OctocryleneACTIVE MOIETY5A68WGF6WMCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
OxybenzoneACTIVE MOIETY95OOS7VE0YCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
.Alpha.-TocopherolINACTIVE INGREDIENTH4N855PNZ1COPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
C13-15 AlkaneINACTIVE INGREDIENT114P5I43UJCOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
IsododecaneINACTIVE INGREDIENTA8289P68Y2COPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2
IsohexadecaneINACTIVE INGREDIENT918X1OUF1ECOPPERTONE WET AND CLEAR KIDS SPF 50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [MSD CONSUMER CARE, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7355-211523735502177 mL in 1 CAN (11523-7355-2) 177 ml2012-03-152021-09-01NoNoCurrent