SUNSCREEN

Product NDC
57367-029
11-digit product format
573670029
Labeler code
57367
Product ID
57367-029_b0602558-795b-4916-b143-74d0e6e6a84c
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
220 Laboratories Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-05-10
Marketing end
0000-00-00
Substance
HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
150 mg/g; mg/g; mg/g; mg/g; mg/g
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 productproduct57367-029IInactivated by FDA2026-10-15
excluded packagepackage57367-02957367-029-05IInactivated by FDA2026-10-15

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 packagepackage57367-029-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57367-029-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57367-029-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57367-029-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57367-029-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57367-029-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57367-029-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57367-029-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57367-029-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57367-029-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57367-029-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57367-029-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57367-029-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57367-029-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57367-029-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57367-029-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57367-029-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57367-029-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57367-029-058dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57367-029-05e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57367-029-059bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57367-029-05110d247fa046…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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57367-029-052019-10-21C16284748780-1956f9ecf-c08a-621f-e053-dbdaa90a74adSPF-30 Artwork

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57367-029-05SUNSCREENWATER RESISTANT106 g in 1 CANAEROSOL, SPRAY1062

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
HOMOSALATEACTIVE MOIETYV06SV4M95SSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
OCTISALATEACTIVE MOIETY4X49Y0596WSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8SUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TUSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41SUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
CORN OILINACTIVE INGREDIENT8470G57WFMSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
COUMARININACTIVE INGREDIENTA4VZ22K1WTSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704ISUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57367-029SUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2Legacy NDC, 1 package rows20100518_6ff3b386-8a20-47de-992c-3d7b5556f5bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57367-029-0557367002905106 g in 1 CAN106 gHistorical