Home NDC 77358-201 Bluevado Sunfix
Product NDC 77358-201
11-digit product format 773580201
Labeler code 77358
Product ID 77358-201_484a56e3-3673-c351-e063-6294a90aa340
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Magic Blue, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-01
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 8.2; 2.8 g/100mL; g/100mL
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 Bluevado Sunfix
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 8.2 g/100mL TITANIUM DIOXIDE 2.8 g/100mL
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 77358-201-03 Bluevado Sunfix 90 mL in 1 TUBE LOTION 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77358-201 BLUEVADO SUNFIX (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [MAGIC BLUE, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240113_2e5315bf-39f4-401c-8207-18ef6a97e024.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 77358-201-03 77358020103 90 mL in 1 TUBE (77358-201-03) 90 ml 2021-12-01 0000-00-00 No No Current