Home NDC 84294-484 MELAN SPF-30 Broad Spectrum
Product NDC 84294-484
11-digit product format 842940484
Labeler code 84294
Product ID 84294-484_177573a4-c184-2b48-e063-6394a90a9a55
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE
Dosage form LOTION
Route TOPICAL
Labeler MELAN INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-06
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 30; 80; 50 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 MELAN SPF-30 Broad Spectrum
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 80 mg/mL OCTISALATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84294-484-00 MELAN SPF-30 Broad Spectrum 100.55 mL in 1 TUBE LOTION 100.55 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84294-484 MELAN SPF-30 BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [MELAN INC.] 1 Current NDC, 1 package rows 20240507_75fcef12-bc33-44a7-acda-77d5d7bca2bc.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 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84294-484-00 84294048400 100.55 mL in 1 TUBE (84294-484-00) 100.55 ml 2024-05-06 No No Current