Home NDC 85416-203 Mineral Fusion Tinted
Product NDC 85416-203
11-digit product format 854160203
Labeler code 85416
Product ID 85416-203_457632ec-dde4-ba16-e063-6394a90a192a
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler FOREFRONT DERMATOLOGY, S.C.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-04
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 80; 38 mg/g; mg/g
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 Mineral Fusion Tinted
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85416-203-15 Mineral Fusion Tinted 15 g in 1 PACKET CREAM 15 2 85416-203-50 Mineral Fusion Tinted 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85416-203 MINERAL FUSION TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FOREFRONT DERMATOLOGY, S.C.] 1 Current NDC, 1 package rows 20250423_334ec844-5560-50f7-e063-6394a90a01be.zip 85416-203 MINERAL FUSION TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FOREFRONT DERMATOLOGY, S.C.] 1 Current NDC, 1 package rows 20250423_334f90d6-68e5-db37-e063-6294a90a5fb1.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 85416-203-15 85416020315 15 g in 1 PACKET (85416-203-15) 15 g 2021-02-04 Yes No Current 85416-203-50 85416020350 53 g in 1 BOTTLE, PUMP (85416-203-50) 53 g 2021-02-04 No No Current