COOLA BARE REPUBLIC CLEARSCREEN SPF100

Product NDC
79753-022
11-digit product format
797530022
Labeler code
79753
Product ID
79753-022_4606a991-9041-efd3-e063-6394a90a98ef
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
2021-10-21
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 50; 100 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 SPF100
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE150 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-022-01COOLA BARE REPUBLIC CLEARSCREEN SPF100148 mL in 1 TUBELOTION1483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-022COOLA BARE REPUBLIC CLEARSCREEN SPF100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC]2Current NDC, Legacy NDC, 1 package rows20241025_f1504311-4865-5499-e053-2995a90acdcd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-022-0179753002201148 mL in 1 TUBE (79753-022-01) 148 ml2021-10-210000-00-00NoNoCurrent