COOLA Classic Body Sunscreen Tropical Coconut

Product NDC
79753-076
11-digit product format
797530076
Labeler code
79753
Product ID
79753-076_a0a84e34-88b1-43ef-9dc6-d375e69d71c2
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
2023-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
17.5; 22.5; 15; 37.5 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 Classic Body Sunscreen Tropical Coconut
Brand name suffix
SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE17.5 mg/mL
HOMOSALATE22.5 mg/mL
OCTISALATE15 mg/mL
OCTOCRYLENE37.5 mg/mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-076-01COOLA Classic Body Sunscreen Tropical CoconutSPF 30148 mL in 1 TUBELOTION1482
79753-076-01COOLA Classic Body Sunscreen Tropical CoconutSPF 301 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-076COOLA CLASSIC BODY SUNSCREEN TROPICAL COCONUT SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA LLC]2Current NDC, 2 package rows20241228_55ad5d2f-a855-491e-a287-13689f8abff1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79753-076-01797530076011 TUBE in 1 CARTON (79753-076-01) / 148 mL in 1 TUBE1 tube2023-02-01NoNoHistorical