COOLA BARE REPUBLIC MINERAL SPORT SPF50

Product NDC
79753-029
11-digit product format
797530029
Labeler code
79753
Product ID
79753-029_45edb38b-e49e-d95f-e063-6394a90ad93c
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
29; 78 mg/mL; mg/mL
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 SPORT SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE29 mg/mL
ZINC OXIDE78 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-029-71COOLA BARE REPUBLIC MINERAL SPORT SPF50148 mL in 1 BOTTLELOTION1483
79753-029-72COOLA BARE REPUBLIC MINERAL SPORT SPF50946 mL in 1 BOTTLELOTION9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-029COOLA BARE REPUBLIC MINERAL SPORT SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [COOLA, LLC]2Current NDC, Legacy NDC, 2 package rows20241025_bbf15e58-c160-d599-e053-2a95a90a0696.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-029-7179753002971148 mL in 1 BOTTLE (79753-029-71) 148 ml2018-11-010000-00-00NoNoCurrent
79753-029-7279753002972946 mL in 1 BOTTLE (79753-029-72) 946 ml2018-11-010000-00-00NoNoCurrent