Home NDC 71398-014 Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark
Product NDC 71398-014
11-digit product format 713980014
Labeler code 71398
Product ID 71398-014_a8d02db9-311d-408e-8283-14e903f5d0bd
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler SENT�, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-10
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 47.43; 87.048 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 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 product product 71398-014 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71398-014 71398-014-01 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.
Additional Listing Data#
Finished product Yes
Brand name base Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 47.43 mg/mL ZINC OXIDE 87.048 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71398-014-01 Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark 50 mL in 1 TUBE LOTION 50 3 71398-014-01 Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark 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 71398-014 EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 36 MEDIUM - DARK (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SENTÉ, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240415_aedde765-931f-430e-9fc3-d87bde2b78cd.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71398-014-01 71398001401 1 TUBE in 1 CARTON (71398-014-01) / 50 mL in 1 TUBE 1 tube 2022-06-10 0000-00-00 No No Current