Home NDC 82757-103 The Mineral Melt SPF30
Product NDC 82757-103
11-digit product format 827570103
Labeler code 82757
Product ID 82757-103_762feb4a-6099-49b5-9423-d3a97740b1c5
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Dune Suncare Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-01
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 48; 23 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 The Mineral Melt SPF30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 48 mg/mL TITANIUM DIOXIDE 23 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82757-103-10 The Mineral Melt SPF30 2 mL in 1 PACKET LOTION 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82757-103 THE MINERAL MELT SPF30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [DUNE SUNCARE INC.] 1 Current NDC, 1 package rows 20240406_2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3.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 353 · 7,049 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82757-103-10 82757010310 2 mL in 1 PACKET (82757-103-10) 2 ml 2023-06-01 No No Current