FDA.reportPublic FDA data

Evereden SPF50 Premium Mineral Sunscreen

Product NDC
72113-107
11-digit product format
721130107
Labeler code
72113
Product ID
72113-107_dcedc364-3cef-d30a-e053-2995a90a7d78
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Eden Brands Inc
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-01-18
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
4 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct72113-107IInactivated by FDA2026-10-05
excluded packagepackage72113-10772113-107-14IInactivated 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct72113-107IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72113-10772113-107-14IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

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
72113-107-142023-03-15C16284748780-1e4f33bdf-afe6-d8a0-e053-dadaa90a6e4eSPF50 Premium Mineral Sunscreen Lotion
72113-107-142022-07-29C16284748780-1e4f33bdf-afe6-d8a0-e053-dadaa90a6e4eSPF50 Premium Mineral Sunscreen Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-107-14Evereden SPF50 Premium Mineral Sunscreen60 mL in 1 BOTTLE, DISPENSINGLOTION603
72113-107-14Evereden SPF50 Premium Mineral Sunscreen1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-107EVEREDEN SPF50 PREMIUM MINERAL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [EDEN BRANDS INC]3Legacy NDC, 2 package rows20231024_dcedc364-3cee-d30a-e053-2995a90a7d78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72113-107-14721130107141 BOTTLE, DISPENSING in 1 CARTON (72113-107-14) > 60 mL in 1 BOTTLE, DISPENSING2022-01-180000-00-00NoNoCurrent