Home NDC 54111-148 COOLA Refreshing Water Mist SPF 18
Product NDC 54111-148
11-digit product format 541110148
Labeler code 54111
Product ID 54111-148_aae99fc7-d6b1-44fc-a2d8-0004df757b85
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Bentley Laboratories, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-30
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 2; 10; 5; 5.5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Refreshing Water Mist SPF 18
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2 g/100mL HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL OCTOCRYLENE 5.5 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54111-148-50 COOLA Refreshing Water Mist SPF 18 1 in 1 CARTON SPRAY 1 3 54111-148-50 COOLA Refreshing Water Mist SPF 18 50 mL in 1 BOTTLE SPRAY 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-148 COOLA REFRESHING WATER MIST SPF 18 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [BENTLEY LABORATORIES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231220_658bf3fe-2246-40b6-8cb1-969bfdaffd1b.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 155 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Alba Botanica Sensitive Mineral SPF 50 ZINC OXIDE The Hain Celestial Group, Inc. 4484b16f-f29a-60cc-e063-6294a90a2b9d 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sheer Mineral SPF50 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9c4b9-8e85-980c-e063-6394a90a9e7e 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sensitive Mineral SPF 30 ZINC OXIDE The Hain Celestial Group, Inc. 44867882-d9c1-7389-e063-6294a90a7f77 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sheer Mineral SPF30 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9361f-f292-6429-e063-6294a90add0e 2025-11-26 Warnings Exact identifier application number: M020 ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. ec8386f2-9cb7-40f4-e053-2995a90ac2d8 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 330a9f2e-7ce1-f83f-e063-6394a90a184a 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 33cdde09-e7ee-e003-e063-6394a90a8762 2025-11-26 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44718c3c-b081-bcfb-e063-6394a90a3786 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472cc1e-6b34-388b-e063-6394a90ac7b6 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472ef69-8992-fcab-e063-6294a90a6b90 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44732f89-8ac3-8c5d-e063-6394a90aba73 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 447347d6-b8a3-7338-e063-6294a90abbf9 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4473c4cc-f8b5-4a92-e063-6394a90ae690 2025-11-25 Warnings Exact identifier application number: M020 salmon colored sunscreen SALMON COLORED SUNSCREEN Guangzhou Fantesy Biotechnology Co.,Ltd 4477964b-28f3-a371-e063-6294a90a4230 2025-11-25 Warnings Exact identifier application number: M020 Safe Sea SPF 50 Mineral ZINC OXIDE Nidaria Technology Ltd. f6cf9454-552b-486e-a38b-ab3c183b24a1 2025-11-24 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 54111-148-50 54111014850 1 BOTTLE in 1 CARTON (54111-148-50) / 50 mL in 1 BOTTLE 1 bottle 2020-07-30 2023-12-31 No No Current