COOLA BARE REPUBLIC CLEARSCREEN SPF50

Product NDC
79753-014
11-digit product format
797530014
Labeler code
79753
Product ID
79753-014_460661f4-fd16-f275-e063-6294a90aa4f4
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 90; 40; 50 mg/mL; mg/mL; 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 CLEARSCREEN SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE90 mg/mL
OCTISALATE40 mg/mL
OCTOCRYLENE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-014-71COOLA BARE REPUBLIC CLEARSCREEN SPF50148 mL in 1 BOTTLELOTION1484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-014COOLA BARE REPUBLIC CLEARSCREEN SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC]3Current NDC, Legacy NDC, 1 package rows20241025_bcbab676-fbe2-f0cc-e053-2a95a90ad4d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-014-7179753001471148 mL in 1 BOTTLE (79753-014-71) 148 ml2021-01-010000-00-00NoNoCurrent