COOLA Classic Body Sunscreen Pina Colada

Product NDC
54111-146
11-digit product format
541110146
Labeler code
54111
Product ID
54111-146_7d0440d0-91bd-4c66-86d7-5e4722d1951a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-06
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.75; 2.5; 1.5; 3.75 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COOLA Classic Body Sunscreen Pina Colada
Brand name suffix
SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.75 g/100mL
HOMOSALATE2.5 g/100mL
OCTISALATE1.5 g/100mL
OCTOCRYLENE3.75 g/100mL

Harmonized Identifiers#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-146-50COOLA Classic Body Sunscreen Pina ColadaSPF 30148 mL in 1 TUBELOTION1485
54111-146-50COOLA Classic Body Sunscreen Pina ColadaSPF 301 in 1 BOXLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-146COOLA CLASSIC BODY SUNSCREEN PINA COLADA SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20231221_d508cef6-977f-4231-8c19-491569e99921.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-146-50541110146501 TUBE in 1 BOX (54111-146-50) / 148 mL in 1 TUBE1 tube2019-11-060000-00-00NoNoCurrent