Mimosa Lane SPF45

Product NDC
84554-0006
11-digit product format
845540006
Labeler code
84554
Product ID
84554-0006_4927bdbf-b986-aa67-e063-6394a90aac39
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate, octisalate, zinc oxide sunscreen
Dosage form
CREAM
Route
TOPICAL
Labeler
R&G Divergency LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-30
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
75; 30; 80 g/1000g; g/1000g; g/1000g
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

Additional Listing Data#

Finished product
Yes
Brand name base
Mimosa Lane SPF45
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 g/1000g
OCTISALATE30 g/1000g
ZINC OXIDE80 g/1000g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, SOI2LOH54Z

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
84554-0006-1Mimosa Lane SPF45150 g in 1 TUBECREAM1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84554-0006MIMOSA LANE SPF45 (OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN) CREAM [R&G DIVERGENCY LLC]2Current NDC, 1 package rows20240831_40f3b8ea-bfa5-4c66-9c79-c4408bda857a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84554-0006-184554000601150 g in 1 TUBE (84554-0006-1) 150 g2024-08-30NoNoHistorical