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 156 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EELHOE Bio Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 349a3d72-9969-855d-e063-6394a90a281c 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Cica Cooling Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305c13af-0843-f478-e063-6394a90a42de 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Quick Sun Stick Protection Bar TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3578c958-a457-402b-e063-6394a90a7342 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Matte Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 42cfa690-15fe-e5de-e063-6394a90a8e71 2025-11-27 Warnings Exact identifier application number: M020 JAYSUING Moisturiser Sun Stick TITANIUM DIOXIDE Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. 42c307d9-aaa9-30df-e063-6294a90aa114 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4494bea6-ab1f-aae6-e063-6394a90a184d 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44853202-6873-0bc8-e063-6394a90a05f0 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 43f43c5a-2680-f549-e063-6394a90aade3 2025-11-27 Warnings Exact identifier application number: M020 Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE THG Beauty USA LLC 44952d01-7f38-0a9c-e063-6394a90a2018 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44954d7c-2a78-3df4-e063-6294a90ab56f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and Coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 449712ab-5c23-7d50-e063-6394a90ab7fe 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44991f67-9160-ccce-e063-6394a90ada1f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4499bcda-f0ba-878e-e063-6394a90a5fc0 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc Kids Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44615ae4-8206-122d-e063-6294a90a0b2c 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 42fd5d3e-4e98-86d7-e063-6294a90a45c2 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375b60f1-ad33-578a-e063-6294a90a1fc6 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for Welding ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386e35de-cd13-f430-e063-6394a90acc84 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Matte Sun Stick TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375bacf7-9372-bff7-e063-6294a90ae67c 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386e23ec-7618-f42c-e063-6394a90a595d 2025-11-27 Warnings Exact identifier application number: M020 KOVR Military grade sunscreen for Men ZINC OXIDE ACTIVE LIFE INC c9fbbc6e-6284-4308-89a3-98300c3a0320 2025-11-26 Warnings 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