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

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
IngredientStrength
ZINC OXIDE180 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72101-419-00BLUE MONARCH Tinted SPF-50 (Rose Gold)1 in 1 BOXCREAM12
72101-419-00BLUE MONARCH Tinted SPF-50 (Rose Gold)35 mL in 1 BOTTLECREAM352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72101-419BLUE MONARCH TINTED SPF-50 (ROSE GOLD) (ZINC OXIDE) CREAM [BLUE MONARCH, LLC]2Current NDC, 2 package rows20231112_9ba00a03-1015-4946-8c9b-5ef377a32e4b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72101-419-00721010419001 BOTTLE in 1 BOX (72101-419-00) / 35 mL in 1 BOTTLE1 bottle2023-08-07NoNoHistorical