keras day shield broad spectrum SPF 25

Product NDC
24854-400
11-digit product format
248540400
Labeler code
24854
Product ID
24854-400_54e717a9-f442-48a5-8aac-eee89f00746d
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate, avobenzone, and octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Keraplast Technologies LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-11-30
Marketing end
0000-00-00
Substance
OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength
0 g/50mL; g/50mL; g/50mL
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 productproduct24854-400IInactivated by FDA2026-10-12
excluded packagepackage24854-40024854-400-50IInactivated by FDA2026-10-12

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 · 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 packagepackage24854-400-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24854-400-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24854-400-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24854-400-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24854-400-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24854-400-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24854-400-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24854-400-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24854-400-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24854-400-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24854-400-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24854-400-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage24854-400-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage24854-400-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage24854-400-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage24854-400-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage24854-400-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage24854-400-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage24854-400-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage24854-400-50e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage24854-400-509bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage24854-400-50110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24854-400-502019-11-13C16284748780-197449f38-d268-f6ea-e053-dbdaa90aa703Day Shield Broad Spectrum SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24854-400-50keras day shield broad spectrum SPF 2550 mL in 1 BOTTLE, PUMPLOTION501
24854-400-50keras day shield broad spectrum SPF 251 in 1 CARTONLOTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
avobenzoneACTIVE INGREDIENTG63QQF2NOXKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
octinoxateACTIVE INGREDIENT4Y5P7MUD51KERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
octocryleneACTIVE INGREDIENT5A68WGF6WMKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
avobenzoneACTIVE MOIETYG63QQF2NOXKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
octinoxateACTIVE MOIETY4Y5P7MUD51KERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
octocryleneACTIVE MOIETY5A68WGF6WMKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
gluconolactoneINACTIVE INGREDIENTWQ29KQ9POTKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4KERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1
waterINACTIVE INGREDIENT059QF0KO0RKERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24854-400KERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST TECHNOLOGIES LLC]1Legacy NDC, 2 package rows20120330_1a784b0e-a517-4510-a547-1334febfc0aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
24854-400-502485404005050 mL in 1 BOTTLE, PUMP50 mlHistorical