FDA.reportPublic FDA data

Dynamic Sunscreen Broad Spectrum SPF 55 Sun Protection

Product NDC
82365-5550
11-digit product format
823655550
Labeler code
82365
Product ID
82365-5550_d001741b-9d62-73f7-e053-2995a90a6a34
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Saguaro Dermatology Associates, L.L.C.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-11-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82365-5550IInactivated by FDA2026-10-12
excluded packagepackage82365-555082365-5550-2IInactivated by FDA2026-10-12

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
82365-5550-22024-01-16C16284748780-1f386c64a-0c28-0266-e053-dadaa90a7c1aDynamic Sunscreen Broad Spectrum SPF 55 Sun Protection
82365-5550-22023-01-30C16284748780-1f386c64a-0c28-0266-e053-dadaa90a7c1aDynamic Sunscreen Broad Spectrum SPF 55 Sun Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82365-5550-2Dynamic Sunscreen Broad Spectrum SPF 55 Sun Protection50 g in 1 BOTTLE, PLASTICCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82365-5550DYNAMIC SUNSCREEN BROAD SPECTRUM SPF 55 SUN PROTECTION (OCTINOXATE AND ZINC OXIDE) CREAM [SAGUARO DERMATOLOGY ASSOCIATES, L.L.C.]2Legacy NDC, 1 package rows20240117_d001798c-62a6-a353-e053-2a95a90a7124.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82365-5550-28236555500250 g in 1 BOTTLE, PLASTIC (82365-5550-2) 50 g2021-11-010000-00-00NoNoCurrent