Peter Island Sunscreen

Product NDC
50390-705
11-digit product format
503900705
Labeler code
50390
Product ID
50390-705_d6626f99-360b-407c-ad4a-c9a9f9258e3c
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
AMWAY CORP.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-11-26
Marketing end
0000-00-00
Substance
HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
10 g/100g; g/100g; g/100g; g/100g; g/100g
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 productproduct50390-705IInactivated by FDA2026-10-05
excluded packagepackage50390-70550390-705-56IInactivated 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 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56IInactivated 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 packagepackage50390-705-56EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50390-705-562020-01-31C16284748780-19d75b9d0-0ee9-f424-e053-dadaa90a57ce1129b564-ed0f-4372-bc94-eef055b01aee

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50390-705-56Peter Island SunscreenSPF 30226 g in 1 BOTTLE, PLASTICLOTION2263

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
HOMOSALATEACTIVE INGREDIENTV06SV4M95SPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
OCTISALATEACTIVE INGREDIENT4X49Y0596WPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
AVOBENZONEACTIVE MOIETYG63QQF2NOXPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
HOMOSALATEACTIVE MOIETYV06SV4M95SPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
OCTISALATEACTIVE MOIETY4X49Y0596WPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
OXYBENZONEACTIVE MOIETY95OOS7VE0YPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
BARIUM SULFATEINACTIVE INGREDIENT25BB7EKE2EPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
JOJOBA OILINACTIVE INGREDIENT724GKU717MPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4PETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
SORBITOLINACTIVE INGREDIENT506T60A25RPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8PETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RPETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50390-705PETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [AMWAY CORP.]3Legacy NDC, 1 package rows20121128_1129b564-ed0f-4372-bc94-eef055b01aee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50390-705-5650390070556226 g in 1 BOTTLE, PLASTIC226 gHistorical