Home NDC 81637-299 PROJECT REEF Mineral Sunscreen SPF-50
Product NDC 81637-299
11-digit product format 816370299
Labeler code 81637
Product ID 81637-299_09e285b2-b615-08b4-e063-6394a90a8964
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, TITANIUM DIOXIDE
Dosage form LOTION
Route TOPICAL
Labeler Project Reef LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-21
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 140; 60 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 PROJECT REEF Mineral Sunscreen SPF-50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 140 mg/mL TITANIUM DIOXIDE 60 mg/mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81637-299-00 PROJECT REEF Mineral Sunscreen SPF-50 946.35 mL in 1 BOTTLE LOTION 946.35 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81637-299 PROJECT REEF MINERAL SUNSCREEN SPF-50 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [PROJECT REEF LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231112_87b9170c-956e-4aa2-9416-da00cca81b58.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 Marketing end Sample Exclude flag Status 81637-299-00 81637029900 946.35 mL in 1 BOTTLE (81637-299-00) 946.35 ml 2022-03-21 0000-00-00 No No Current