Home NDC 54111-145 COOLA Classic Body Sunscreen Fragrance-Free
Product NDC 54111-145
11-digit product format 541110145
Labeler code 54111
Product ID 54111-145_5368324e-9b83-48dc-8ab3-88146d9423f8
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; 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 54111-145-51 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 54111-145-51 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 54111-145-51 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base COOLA Classic Body Sunscreen Fragrance-Free
Brand name suffix SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 1.75 g/100mL HOMOSALATE 5 g/100mL OCTISALATE 2 g/100mL OCTOCRYLENE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54111-145-51 COOLA Classic Body Sunscreen Fragrance-FreeSPF 50 148 mL in 1 TUBE LOTION 148 6 54111-145-51 COOLA Classic Body Sunscreen Fragrance-FreeSPF 50 1 in 1 BOX LOTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-145 COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20231221_57f2fdeb-2abc-4ad3-bb89-5faee883c0e5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54111-145-51 54111014551 1 TUBE in 1 BOX (54111-145-51) / 148 mL in 1 TUBE 1 tube 2019-11-06 2023-12-31 No No Current