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 128 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Sheer Sunscreen ZINC OXIDE SKINBAR MD LLC 35810a90-e2ca-b80b-e063-6294a90a14f0 2025-12-12 Exact identifier application number: M020 Tinted Facial Mineral Sunscreen SPF 40 TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 3531d609-a0d8-cb59-e063-6394a90a4bea 2025-12-12 Exact identifier application number: M020 Non-Tinted Zinc Body And Face SPF40 ZINC OXIDE RSL89 LLC 3532102c-8ded-1e78-e063-6294a90ae224 2025-12-12 Exact identifier application number: M020 Non-Tinted Zinc Body And Face SPF40 ZINC OXIDE RSL89 LLC 35330a82-dc6b-49af-e063-6394a90af9ea 2025-12-12 Exact identifier application number: M020 Tinted Replenishing SPF40 ZINC OXIDE RSL89 LLC 353257db-6c30-4a03-e063-6294a90ae45d 2025-12-12 Exact identifier application number: M020 Tinted Facial Mineral Sunscreen SPF 40 TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 3532a6a2-dbb5-8111-e063-6294a90aeaeb 2025-12-12 Exact identifier application number: M020 Tinted Replenishing SPF40 ZINC OXIDE RSL89 LLC 35334c75-b3fd-37fa-e063-6294a90ab3b0 2025-12-12 Exact identifier application number: M020 Age Defying Sunscreen ZINC OXIDE GINAMARIE Products 35835565-f10b-e8e7-e063-6394a90ab2d3 2025-12-12 Exact identifier application number: M020 Tinted Daily Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 35338026-525a-d8b3-e063-6394a90a98f5 2025-12-12 Exact identifier application number: M020 Mineral Lip Protection TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 3541971e-3664-a9f5-e063-6294a90ac2d2 2025-12-12 Exact identifier application number: M020 Age Defying Sunscreen ZINC OXIDE GINAMARIE Products 35837cf7-91e5-f9ec-e063-6394a90aa91e 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Face plus Body ZINC OXIDE KS Esthetics, LLC 390a4d8d-b47f-0d9a-e063-6394a90a9b53 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Tinted Zinc Oxide ZINC OXIDE KS Esthetics, LLC 3909e657-97a5-dd3c-e063-6394a90a10eb 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 36608832-22d8-bc76-e063-6394a90abac6 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660af9e-d60f-c33e-e063-6394a90a3a05 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 366149e2-b03c-e798-e063-6394a90a6a1d 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660e701-1373-eef4-e063-6394a90a6140 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 3661251d-b907-8df6-e063-6294a90a1c73 2025-12-12 Exact identifier application number: M020 sheer tinted sunscreen TITANIUM DIOXIDE, ZINC OXIDE SARA ELIZABETH SKINCARE 3b177c49-ed8c-42b9-e063-6294a90a82c6 2025-12-12 Warnings Exact identifier application number: M020 Canopy Untinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 35824cd5-0036-7886-e063-6394a90ae678 2025-12-12 Exact identifier application number: M020
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