Home NDC 85563-258 Sheer Tinted Protection
Product NDC 85563-258
11-digit product format 855630258
Labeler code 85563
Product ID 85563-258_460420ec-9409-2620-e063-6294a90a85cc
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler CLEAR SKIN SOLUTIONS, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-21
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 30; 100 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 Sheer Tinted Protection
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 30 mg/g TITANIUM DIOXIDE 100 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 85563-258-50 Sheer Tinted Protection 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 85563-258 SHEER TINTED PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [CLEAR SKIN SOLUTIONS, LLC] 1 Current NDC, 1 package rows 20250524_35bd62d8-ebe3-b3fd-e063-6394a90a827c.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 85563-258-50 85563025850 50 g in 1 BOTTLE, PUMP (85563-258-50) 50 g 2025-02-21 No No Current