Home NDC 85356-201 Mineral Primer tinted SPF40
Product NDC 85356-201
11-digit product format 853560201
Labeler code 85356
Product ID 85356-201_46001ae9-9f4d-7837-e063-6394a90a6bdf
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Oracle Esthetics, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-18
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 38; 80 mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Primer tinted SPF40
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 38 mg/g TITANIUM DIOXIDE 80 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP 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 85356-201-85 Mineral Primer tinted SPF40 85 g in 1 BOTTLE, PUMP CREAM 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85356-201 MINERAL PRIMER TINTED SPF40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ORACLE ESTHETICS, LLC] 1 Current NDC, 1 package rows 20250519_3542d8d3-35a3-7d63-e063-6394a90a6fd1.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 242 of 353 · 7,041 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85356-201-85 85356020185 85 g in 1 BOTTLE, PUMP (85356-201-85) 85 g 2020-05-18 No No Current