Home NDC 81679-258 SPF 50 Mineral Based Facial Sunscreen
Product NDC 81679-258
11-digit product format 816790258
Labeler code 81679
Product ID 81679-258_d1612c94-e50e-4ba5-a591-a7dfa77fb5f8
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Hutton, Kathleen MD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-25
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 100; 30 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 SPF 50 Mineral Based Facial Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 100 mg/g ZINC OXIDE 30 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 81679-258-50 SPF 50 Mineral Based Facial Sunscreen 53 g in 1 BOTTLE, PUMP CREAM 53 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81679-258 SPF 50 MINERAL BASED FACIAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HUTTON, KATHLEEN MD] 1 Current NDC, 1 package rows 20240329_5cf0d2e3-d496-424c-ac75-70ff5b87e9ca.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 81679-258-50 81679025850 53 g in 1 BOTTLE, PUMP (81679-258-50) 53 g 2024-03-25 No No Current