Coppertone Sensitive Skin

Product NDC
11523-7300
11-digit product format
115237300
Labeler code
11523
Product ID
11523-7300_8f613fde-822b-27b5-e053-2995a90a8352
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1999-05-21
Marketing end
2019-12-01
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
85 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11523-7300DDiscontinued by firm2026-10-15
excluded packagepackage11523-730011523-7300-1DDiscontinued by firm2026-10-15
excluded packagepackage11523-730011523-7300-2DDiscontinued by firm2026-10-15
excluded packagepackage11523-730011523-7300-3DDiscontinued by firm2026-10-15

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 · 48 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 packagepackage11523-7300-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-7300-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-7300-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-7300-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-7300-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-7300-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11523-7300-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11523-7300-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11523-7300-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11523-7300-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11523-7300-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11523-7300-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11523-7300-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11523-7300-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11523-7300-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11523-7300-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11523-7300-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11523-7300-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11523-7300-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11523-7300-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11523-7300-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11523-7300-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11523-7300-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11523-7300-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11523-7300-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11523-7300-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11523-7300-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-7300-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-7300-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-7300-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-7300-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-7300-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-7300-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-7300-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-7300-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-7300-3557ba5c1ecfa…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
OctinoxateACTIVE INGREDIENT4Y5P7MUD51COPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
OctisalateACTIVE INGREDIENT4X49Y0596WCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
octinoxateACTIVE MOIETY4Y5P7MUD51COPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
octisalateACTIVE MOIETY4X49Y0596WCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW4COPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
Ethylhexyl PalmitateINACTIVE INGREDIENT2865993309COPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3COPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RCOPPERTONE SENSITIVE SKIN SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [MSD CONSUMER CARE, INC.]2