Sei Bella

Product NDC
54473-186
11-digit product format
544730186
Labeler code
54473
Product ID
54473-186_58c8da02-a1d6-492e-9bc1-c5c26fac5ec5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-05-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
1 g/50mL; g/50mL; 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 productproduct54473-186IInactivated by FDA2026-10-05
excluded packagepackage54473-18654473-186-02IInactivated 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 packagepackage54473-186-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54473-186-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54473-186-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54473-186-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54473-186-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54473-186-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54473-186-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54473-186-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54473-186-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54473-186-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54473-186-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54473-186-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54473-186-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54473-186-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54473-186-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54473-186-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54473-186-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54473-186-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54473-186-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54473-186-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54473-186-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54473-186-02110d247fa046…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
54473-186-022019-10-29C16284748780-1960f7f55-cc6e-8e05-e053-dbdaa90a074aSei Bella Daytime Delivery Creme Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-186-02Sei BellaDaytime Delivery1 in 1 BOXCREAM11
54473-186-02Sei BellaDaytime Delivery50 mL in 1 JARCREAM501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
OxybenzoneACTIVE MOIETY95OOS7VE0YSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXISEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
C14-22 ALCOHOLSINACTIVE INGREDIENTB1K89384RJSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60SEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0GSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RSEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-186SEI BELLA DAYTIME DELIVERY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MELALEUCA, INC.]1Legacy NDC, 2 package rows20110203_af2086a9-eae0-484e-aa9f-9697e2b05fb5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54473-186-02544730186021 in 1 BOXHistorical