Home NDC 85338-208 Healthy Mineral Sunscreen No Shine plus Tint
Product NDC 85338-208
11-digit product format 853380208
Labeler code 85338
Product ID 85338-208_45760601-5431-5497-e063-6294a90a5c82
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Zen Dermatology, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-17
Substance ZINC OXIDE
Active strength 160 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 Healthy Mineral Sunscreen No Shine plus Tint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 85338-208-50 Healthy Mineral Sunscreen No Shine plus Tint 50 g in 1 BOTTLE, PUMP CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85338-208 HEALTHY MINERAL SUNSCREEN NO SHINE PLUS TINT (ZINC OXIDE) CREAM [ZEN DERMATOLOGY, INC.] 1 Current NDC, 1 package rows 20250330_31576340-cb11-d944-e063-6294a90adef2.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 85338-208-50 85338020850 50 g in 1 BOTTLE, PUMP (85338-208-50) 50 g 2024-04-17 No No Current