Home NDC 85470-203 ProtectME Tinted Mineral SPF 40
Product NDC 85470-203
11-digit product format 854700203
Labeler code 85470
Product ID 85470-203_459b16dd-28f9-c29a-e063-6294a90af140
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler PUREFECTION LA, INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-08
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 ProtectME Tinted Mineral SPF 40
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 85470-203-50 ProtectME Tinted Mineral SPF 40 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 85470-203 PROTECTME TINTED MINERAL SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PUREFECTION LA, INC.] 1 Current NDC, 1 package rows 20250429_33dccd5d-8db1-f699-e063-6394a90a59a2.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 85470-203-50 85470020350 53 g in 1 BOTTLE, PUMP (85470-203-50) 53 g 2022-12-08 No No Current