Home NDC 54414-028 DERMATONE SPF50 Sunscreen
Product NDC 54414-028
11-digit product format 544140028
Labeler code 54414
Product ID 54414-028_518d22d6-884f-7c55-e063-6294a90a63a8
Type HUMAN OTC DRUG
Nonproprietary name Avabenzone 3% Homosalate 10% Octisalate 5%
Dosage form SPRAY
Route TOPICAL
Labeler Dermatone Labs LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-06
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 3; 10; 5 g/100g; g/100g; g/100g
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 DERMATONE SPF50 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100g HOMOSALATE 10 g/100g OCTISALATE 5 g/100g
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 54414-028-05 DERMATONE SPF50 Sunscreen 141 g in 1 CAN SPRAY 141 2
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 Sample Exclude flag Status 54414-028-05 54414002805 141 g in 1 CAN (54414-028-05) 141 g 2025-08-06 No No Current