Sun Shades

Product NDC
54473-212
11-digit product format
544730212
Labeler code
54473
Product ID
54473-212_0c735b37-5321-4523-99fa-f62acba87672
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-04-30
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
5 g/177mL; g/177mL; g/177mL; g/177mL
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 productproduct54473-212IInactivated by FDA2026-10-16
excluded packagepackage54473-21254473-212-06IInactivated by FDA2026-10-16

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 packagepackage54473-212-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54473-212-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54473-212-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54473-212-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54473-212-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54473-212-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54473-212-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54473-212-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54473-212-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54473-212-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54473-212-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54473-212-06557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54473-212-068af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54473-212-06834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54473-212-061332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54473-212-06fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54473-212-0686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54473-212-06bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54473-212-068dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54473-212-06e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54473-212-069bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54473-212-06110d247fa046…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
54473-212-062019-11-13C16284748780-197449f38-cf56-f6ea-e053-dbdaa90aa703Sun Shades Sport 45+ Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-212-06Sun ShadesSport Plus177 mL in 1 CANSPRAY1772

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
HOMOSALATEACTIVE MOIETYV06SV4M95SSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
OCTISALATEACTIVE MOIETY4X49Y0596WSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
BIXA ORELLANA SEEDINACTIVE INGREDIENTO87354RZ5ASUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
MACADAMIA OILINACTIVE INGREDIENT515610SU8CSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RSUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2
PROPYLENE GLYCOL DIBENZOATEINACTIVE INGREDIENTEQY32Z1AN4SUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-212SUN SHADES SPORT PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA, INC.]2Legacy NDC, 1 package rows20120404_42a61346-ed7d-4537-b467-4585cc229aac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54473-212-0654473021206177 mL in 1 CAN177 mlHistorical