Home NDC 85591-208 Tinted Mineral Defense SPF 40
Product NDC 85591-208
11-digit product format 855910208
Labeler code 85591
Product ID 85591-208_4614dcdf-bcfb-27d8-e063-6294a90a9804
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler JOSEPHINA RAMIREZ
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-16
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 Tinted Mineral Defense SPF 40
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 85591-208-50 Tinted Mineral Defense SPF 40 50 g in 1 BOTTLE, PUMP CREAM 50 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 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 85591-208-50 85591020850 50 g in 1 BOTTLE, PUMP (85591-208-50) 50 g 2022-11-16 No No Current