RITE AID RENEWAL

Product NDC
11822-3410
11-digit product format
118223410
Labeler code
11822
Product ID
11822-3410_960eece5-bd7b-4185-9456-a84039f26e05
Type
HUMAN OTC DRUG
Nonproprietary name
ENSULIZOLE
Dosage form
LOTION
Route
TOPICAL
Labeler
RITE AID CORPORATION
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-07-21
Marketing end
0000-00-00
Substance
ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE
Active strength
2 mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct11822-3410IInactivated by FDA2026-08-17
excluded packagepackage11822-341011822-3410-2IInactivated by FDA2026-08-17

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-3410-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11822-3410-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11822-3410-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11822-3410-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-3410-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-3410-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-3410-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-3410-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-3410-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11822-3410-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11822-3410-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11822-3410-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11822-3410-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11822-3410-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11822-3410-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11822-3410-2IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11822-3410-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11822-3410-2IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11822-3410-2IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11822-3410-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11822-3410-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11822-3410-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-3410-22020-01-31C16284748780-19d75b9d1-006f-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3410-2RITE AID RENEWALSUNSCREEN50 mL in 1 TUBELOTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W42RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W42RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VCRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
1,2-BUTANEDIOLINACTIVE INGREDIENTRUN0H01QEURITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
ANISACRILINACTIVE INGREDIENT5TB1FV429ZRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
BEHENYL PHOSPHATEINACTIVE INGREDIENT366D9UAY69RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
CETETH-10 PHOSPHATEINACTIVE INGREDIENT4E05O5N49GRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
CODIUM TOMENTOSUMINACTIVE INGREDIENTB8B45BRU87RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BARITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
DIHEXADECYL PHOSPHATEINACTIVE INGREDIENT2V6E5WN99NRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
GUAR GUMINACTIVE INGREDIENTE89I1637KERITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ERITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
SAFFLOWERINACTIVE INGREDIENT4VBL71TY4YRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ERITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
TRIMETHYLOLPROPANE TRIETHYLHEXANOATEINACTIVE INGREDIENTB952ZGW1ILRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RRITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3410RITE AID RENEWAL SUNSCREEN (ENSULIZOLE) LOTION [RITE AID CORPORATION]1Legacy NDC, 1 package rows20110722_e9d28e14-b847-4915-8620-2e9fd5eb6e04.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11822-3410-21182234100250 mL in 1 TUBE50 mlHistorical