Waterblock Solar

Product NDC
21839-091
11-digit product format
218390091
Labeler code
21839
Product ID
21839-091_6f3d5cc8-cae0-47e5-be32-356236a5613f
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octinoxate, Octisalate, Octocrylene, and Oxybenzone
Dosage form
LIQUID
Route
TOPICAL
Labeler
Gordon Laboratories, Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-11-01
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
13 mL/125mL; mL/125mL; mL/125mL; mL/125mL; mL/125mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21839-091IInactivated by FDA2026-10-05
excluded packagepackage21839-09121839-091-25IInactivated by FDA2026-10-05

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 · 44 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 packagepackage21839-091-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21839-091-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21839-091-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21839-091-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21839-091-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21839-091-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21839-091-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21839-091-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21839-091-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21839-091-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21839-091-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21839-091-25557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21839-091-258af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21839-091-25834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21839-091-251332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21839-091-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21839-091-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21839-091-25bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21839-091-258dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21839-091-25e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21839-091-259bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21839-091-25110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-091-252019-11-13C16284748780-197449f38-cab5-f6ea-e053-dbdaa90aa703Dermalogica ® waterblock solar spray spf 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-091-25Waterblock Solar SPF 301 in 1 BOXLIQUID11
21839-091-25Waterblock Solar SPF 30125 mL in 1 BOTTLE, PLASTICLIQUID1251

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95SWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OctisalateACTIVE INGREDIENT4X49Y0596WWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OctocryleneACTIVE INGREDIENT5A68WGF6WMWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
HomosalateACTIVE MOIETYV06SV4M95SWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OctinoxateACTIVE MOIETY4Y5P7MUD51WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OctisalateACTIVE MOIETY4X49Y0596WWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OctocryleneACTIVE MOIETY5A68WGF6WMWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
OxybenzoneACTIVE MOIETY95OOS7VE0YWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Butyloctyl SalicylateINACTIVE INGREDIENT2EH13UN8D3WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Citrus Maxima Fruit Rind OilINACTIVE INGREDIENT8U3877WD44WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Coco-glyceridesINACTIVE INGREDIENTISE9I7DNUGWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Dicaprylyl EtherINACTIVE INGREDIENT77JZM5516ZWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Diisopropyl AdipateINACTIVE INGREDIENTP7E6YFV72XWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
IsododecaneINACTIVE INGREDIENTA8289P68Y2WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Melissa Officinalis LeafINACTIVE INGREDIENT50D2ZE9219WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVCWATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-091WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1Legacy NDC, 2 package rows20111117_6f06c25e-350b-4a3c-b034-7db00541e03a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21839-091-25218390091251 in 1 BOXHistorical