Coola Bare Republic Mineral Face-Lotion

Product NDC
79753-041
11-digit product format
797530041
Labeler code
79753
Product ID
79753-041_2afb4f90-07f2-4b17-afb2-7d57e211ab6b
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%
Dosage form
LOTION
Route
TOPICAL
Labeler
COOLA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
3.5; 15.8 g/100mL; g/100mL
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
Coola Bare Republic Mineral Face-Lotion
Brand name suffix
SPF 70
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE3.5 g/100mL
ZINC OXIDE15.8 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, 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
79753-041-01Coola Bare Republic Mineral Face-LotionSPF 7059 mL in 1 TUBELOTION592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-041COOLA BARE REPUBLIC MINERAL FACE-LOTION SPF 70 (TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%) LOTION [COOLA LLC]2Current NDC, Legacy NDC, 1 package rows20231221_a334a61d-5c5a-4f45-b202-6dd7bb3d250b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-041-017975300410159 mL in 1 TUBE (79753-041-01) 59 ml2020-05-010000-00-00NoNoCurrent