Home NDC 83741-480 MIRABELLA Broad Spectrum SPF 30 Sunscreen
Product NDC 83741-480
11-digit product format 837410480
Labeler code 83741
Product ID 83741-480_17c8c23c-4be5-8d00-e063-6394a90a941b
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, AVOBENZONE
Dosage form CREAM
Route TOPICAL
Labeler GDM ENTERPRISES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-06
Substance HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength 100; 50; 30 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 MIRABELLA Broad Spectrum SPF 30 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL AVOBENZONE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 83741-480-00 MIRABELLA Broad Spectrum SPF 30 Sunscreen 1 in 1 BOX CREAM 1 1 83741-480-00 MIRABELLA Broad Spectrum SPF 30 Sunscreen 40 mL in 1 BOTTLE, PUMP CREAM 40 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83741-480 MIRABELLA BROAD SPECTRUM SPF 30 SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE) CREAM [GDM ENTERPRISES LLC] 1 Current NDC, 2 package rows 20240507_3ac847d5-a75d-4b32-84e1-70e4282c0d72.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 Marketing start Sample Exclude flag Status 83741-480-00 83741048000 1 BOTTLE, PUMP in 1 BOX (83741-480-00) / 40 mL in 1 BOTTLE, PUMP 2024-05-06 No No Current