Home NDC 82240-619 Dermaka Sunscreen SPF 42, Tinted
Product NDC 82240-619
11-digit product format 822400619
Labeler code 82240
Product ID 82240-619_37b123bf-b595-e935-e063-6394a90a6dd0
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler DERMAKA SKIN PRODUCTS
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-03
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 60; 77 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Dermaka Sunscreen SPF 42, Tinted
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 60 mg/mL ZINC OXIDE 77 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z 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 82240-619-00 Dermaka Sunscreen SPF 42, Tinted 5 mL in 1 PACKET CREAM 5 1
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 82240-619-00 82240061900 5 mL in 1 PACKET (82240-619-00) 5 ml 2025-06-03 No No Current