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 142 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Foam Weightless Sunscreen Non-Tinted Drytouch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 335ec22c-6a9a-c4d1-e063-6394a90ac0b0 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Non-Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3360a208-5f17-a74b-e063-6294a90a13e1 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 323356ea-31a0-6ff0-e063-6294a90a135c 2025-12-09 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32330376-5db0-202b-e063-6294a90add15 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 32354468-94a2-604b-e063-6394a90adfb5 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 32346536-f542-ef0f-e063-6394a90a0464 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Untinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 3234b498-5b56-55f4-e063-6294a90a9b87 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 3235a696-92aa-788c-e063-6394a90a0149 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32351db0-884c-8fa0-e063-6294a90acba2 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 3235786d-7ba9-c9ab-e063-6294a90a7f2e 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 31416d04-2d6f-7cf9-e063-6294a90a9806 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen Non-Tinted ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143968a-096e-b9ac-e063-6294a90ada0d 2025-12-09 Warnings Exact identifier application number: M020 Daily Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 314299b1-a78b-c1bd-e063-6294a90ab43b 2025-12-09 Warnings Exact identifier application number: M020 Sheer Satin Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143d8b0-4af8-f52d-e063-6294a90a926b 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3142ed0f-f379-f240-e063-6294a90a5303 2025-12-09 Warnings Exact identifier application number: M020 Sheer Non-Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33d83cfb-045d-141c-e063-6394a90a2e04 2025-12-09 Exact identifier application number: M020 First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 45875865-5e9c-d652-e063-6394a90ad5fa 2025-12-09 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b7584-c782-fe9e-e063-6394a90a76fe 2025-12-09 Exact identifier application number: M020 Transparent Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33dbfd9b-b90f-bb32-e063-6294a90af7dc 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b46ac-6dde-72d1-e063-6294a90a03da 2025-12-09 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