Home NDC 54414-027 Dermatone Sport SPF 50
Product NDC 54414-027
11-digit product format 544140027
Labeler code 54414
Product ID 54414-027_46b5b1f6-2248-d0d7-e063-6294a90a335f
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone 3%, Homosalate 10%, Octocrylene 6%
Dosage form LOTION
Route TOPICAL
Labeler Dermatone Labs LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-26
Substance AVOBENZONE; HOMOSALATE
Active strength 3; 10 g/100mL; g/100mL
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 Dermatone Sport SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 10 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup V06SV4M95S 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 54414-027-11 Dermatone Sport SPF 50 3784 mL in 1 CONTAINER LOTION 3784 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 27 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 54414-027-11 54414002711 3784 mL in 1 CONTAINER (54414-027-11) 3784 ml 2022-06-26 No No Current