COOLA Classic Face Sunscreen Fragrance-Free

Product NDC
79753-074
11-digit product format
797530074
Labeler code
79753
Product ID
79753-074_684dd468-00d8-4824-8dd5-17a82f596573
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; 50; 20; 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 Classic Face Sunscreen Fragrance-Free
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE17.5 mg/mL
HOMOSALATE50 mg/mL
OCTISALATE20 mg/mL
OCTOCRYLENE50 mg/mL

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-074-01COOLA Classic Face Sunscreen Fragrance-FreeSPF 501 in 1 CARTONLOTION13
79753-074-01COOLA Classic Face Sunscreen Fragrance-FreeSPF 5050 mL in 1 TUBELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-074COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA LLC]3Current NDC, 2 package rows20241228_12ff4689-f7e2-49db-8848-608c61b41ef0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79753-074-01797530074011 TUBE in 1 CARTON (79753-074-01) / 50 mL in 1 TUBE1 tube2023-02-01NoNoHistorical