Home NDC 54414-048 Dermatone SPF 30
Product NDC 54414-048
11-digit product format 544140048
Labeler code 54414
Product ID 54414-048_32e594c6-6baf-91c3-e063-6394a90ae2a1
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Dermatone Labs LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-26
Substance HOMOSALATE; OCTOCRYLENE; AVOBENZONE
Active strength 7; 5; 1.8 g/100mL; 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 SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 7 g/100mL OCTOCRYLENE 5 g/100mL AVOBENZONE 1.8 g/100mL
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 5A68WGF6WM Internal UNII lookup G63QQF2NOX 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 54414-048-01 Dermatone SPF 30 89 mL in 1 TUBE LOTION 89 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54414-048 DERMATONE SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [DERMATONE LABS LLC] 9 Current NDC, 1 package rows 20250418_32e5bddf-a0b5-c511-e063-6294a90aaf66.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 Sample Exclude flag Status 54414-048-01 54414004801 89 mL in 1 TUBE (54414-048-01) 89 ml 2022-06-26 No No Current