Home NDC 71398-012-01 Invisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen
Product NDC 71398-012
Requested package NDC 71398-012-01
11-digit product format 713980012
Labeler code 71398
Product ID 71398-012_e82edd9a-f3d3-459d-b68c-d21829313a5b
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler SENT
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-05-15
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 58 mg/g; mg/g
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71398-012 71398-012-01 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71398-012-01 Invisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen 52 g in 1 TUBE LOTION 52 3 71398-012-01 Invisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen 1 in 1 CARTON LOTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71398-012 INVISIBLE SHIELD FULL PHYSICAL TINTED SPF 52 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SENTÉ, INC.] 3 Legacy NDC, 2 package rows 20240410_7553d6c9-1d23-4326-bb08-b0aaf2b42a7a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71398-012-01 71398001201 1 TUBE in 1 CARTON (71398-012-01) > 52 g in 1 TUBE 1 tube 2019-05-15 0000-00-00 No No Current