COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum

Product NDC
54111-143
11-digit product format
541110143
Labeler code
54111
Product ID
54111-143_1d1f3d4a-c17a-42b2-af85-54167ab7921f
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
2019-11-07
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.75; 5; 2; 5 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 FACE SUNSCREEN White Tea Broad Spectrum
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.75 g/100mL
HOMOSALATE5 g/100mL
OCTISALATE2 g/100mL
OCTOCRYLENE5 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
54111-143-50COOLA CLASSIC FACE SUNSCREEN White Tea Broad SpectrumSPF 5050 mL in 1 TUBELOTION503
54111-143-50COOLA CLASSIC FACE SUNSCREEN White Tea Broad SpectrumSPF 501 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-143COOLA CLASSIC FACE SUNSCREEN WHITE TEA BROAD SPECTRUM SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC]3Current NDC, Legacy NDC, 2 package rows20231220_4e0e426d-f037-428f-98f2-2d3e945bd040.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-143-50541110143501 TUBE in 1 CARTON (54111-143-50) / 50 mL in 1 TUBE1 tube2019-11-072023-12-31NoNoCurrent