Home NDC 82912-322 PROTEKT SPF-50 Sheer Mineral Sunscreen
Product NDC 82912-322
11-digit product format 829120322
Labeler code 82912
Product ID 82912-322_48c0c89a-eeb6-e9dd-e063-6394a90a7236
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Protekt Products, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-01
Substance ZINC OXIDE
Active strength 180 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 PROTEKT SPF-50 Sheer Mineral Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 180 mg/mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82912-322-00 PROTEKT SPF-50 Sheer Mineral Sunscreen 88 mL in 1 TUBE CREAM 88 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82912-322 PROTEKT SPF-50 SHEER MINERAL SUNSCREEN (ZINC OXIDE) CREAM [PROTEKT PRODUCTS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20231112_6edc0941-bb21-4797-a875-81f727694774.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 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82912-322-00 82912032200 88 mL in 1 TUBE (82912-322-00) 88 ml 2022-07-01 0000-00-00 No No Current