Home NDC 72101-419 BLUE MONARCH Tinted SPF-50 (Rose Gold)
Product NDC 72101-419
11-digit product format 721010419
Labeler code 72101
Product ID 72101-419_09dc64a4-8580-ddca-e063-6294a90ab8f1
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Blue Monarch, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-07
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 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 BLUE MONARCH Tinted SPF-50 (Rose Gold)
Listing expiration 2026-12-31 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 72101-419-00 BLUE MONARCH Tinted SPF-50 (Rose Gold) 1 in 1 BOX CREAM 1 2 72101-419-00 BLUE MONARCH Tinted SPF-50 (Rose Gold) 35 mL in 1 BOTTLE CREAM 35 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72101-419 BLUE MONARCH TINTED SPF-50 (ROSE GOLD) (ZINC OXIDE) CREAM [BLUE MONARCH, LLC] 2 Current NDC, 2 package rows 20231112_9ba00a03-1015-4946-8c9b-5ef377a32e4b.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 72101-419-00 72101041900 1 BOTTLE in 1 BOX (72101-419-00) / 35 mL in 1 BOTTLE 1 bottle 2023-08-07 No No Current