Sunscreen Broad Spectrum SPF 55 Moisturizing

Product NDC
81413-5550
Requested package NDC
81413-5550-2
11-digit product format
814135550
Labeler code
81413
Product ID
81413-5550_b985508d-a428-2d40-e053-2a95a90a3ab6
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Scarsdale Integrative Family Medicine Pllc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-22
Marketing end
0000-00-00
Substance
OCTINOXATE; ZINC OXIDE
Active strength
75 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage81413-555081413-5550-2IInactivated 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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
81413-5550-22023-01-30C16284748780-1f386c64a-3b8b-0266-e053-dadaa90a7c1aSunscreen Broad Spectrum SPF 55 Moisturizing Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81413-5550-2Sunscreen Broad Spectrum SPF 55 Moisturizing50 g in 1 BOTTLE, PLASTICCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81413-5550SUNSCREEN BROAD SPECTRUM SPF 55 MOISTURIZING (OCTINOXATE AND ZINC OXIDE) CREAM [SCARSDALE INTEGRATIVE FAMILY MEDICINE PLLC]1Legacy NDC, 1 package rows20210126_b9856818-4e23-ebfe-e053-2a95a90a6b4e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81413-5550-28141355500250 g in 1 BOTTLE, PLASTIC (81413-5550-2) 50 g2021-01-220000-00-00NoNoCurrent