Home NDC 54111-146 COOLA Classic Body Sunscreen Pina Colada
Product NDC 54111-146
11-digit product format 541110146
Labeler code 54111
Product ID 54111-146_7d0440d0-91bd-4c66-86d7-5e4722d1951a
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; 2.5; 1.5; 3.75 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 54111-146-50 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 54111-146-50 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 54111-146-50 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 Pina Colada
Brand name suffix SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 1.75 g/100mL HOMOSALATE 2.5 g/100mL OCTISALATE 1.5 g/100mL OCTOCRYLENE 3.75 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 54111-146-50 COOLA Classic Body Sunscreen Pina ColadaSPF 30 148 mL in 1 TUBE LOTION 148 5 54111-146-50 COOLA Classic Body Sunscreen Pina ColadaSPF 30 1 in 1 BOX LOTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-146 COOLA CLASSIC BODY SUNSCREEN PINA COLADA SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20231221_d508cef6-977f-4231-8c19-491569e99921.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 51 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunscreen SPF 50 SUNSCREEN SPF 50 Guangzhou Ariel Biotech Co., Ltd. 4dd1b722-4448-9675-e063-6294a90a5f4f 2026-03-24 Warnings Exact identifier application number: M020 Sky and Sol Face and Body Sunscreen SPF30 NON- NANO ZINC OXIDE Delta Ecommerce LLC 2dda185c-6ff8-953d-e063-6394a90acc53 2026-03-24 Warnings Exact identifier application number: M020 WHAMISA ORGANIC PEAR BLOSSOM SUNSCREEN ZINC OXIDE ENS KOREA Co., Ltd. 34f9688d-efa1-1d3f-e063-6294a90ab127 2026-03-23 Warnings Exact identifier application number: M020 HALORINNA SUN-SCREEN TRAVEL SPF50 SUN SCREEN Guangdong Bisutang Biotechnology Co., LTD 4dade579-ce77-eea5-e063-6394a90ad46a 2026-03-23 Warnings Exact identifier application number: M020 TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVE ZINC OXIDE TIRTIR USA Inc. 4c92db00-59f1-ac02-e063-6394a90a7cf1 2026-03-23 Warnings Exact identifier application number: M020 Zinc Oxide 20% SUNSCREEN SPF 50 The Soleil Group, LLC 27d20573-0b6b-4d4b-94ca-69b476a883a7 2026-03-23 Warnings Exact identifier application number: M020 Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. 4db37efb-2d37-7428-e063-6394a90a10e4 2026-03-23 Warnings Exact identifier application number: M020 All Good Mineral Sport Sunscreen Butter ZINC OXIDE Elemental Herbs, Inc. ff334e9c-dd12-92bc-e053-6394a90aa24b 2026-03-23 Warnings Exact identifier application number: M020 All Good Tinted Mineral Sunscreen Butter SPF 50 ZINC OXIDE Elemental Herbs, Inc. fe2bf779-e8b3-933f-e053-6394a90a369f 2026-03-23 Warnings Exact identifier application number: M020 ULTRA SOOTHER DRY-TOUCH SUNSCREEN HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE skinnplus 4dbc1035-c41c-308c-e063-6394a90a36c4 2026-03-23 Warnings Exact identifier application number: M020 Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33 ZINC OXIDE Eva's Esthetics 0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc7 2026-03-23 Warnings Exact identifier application number: M020 MELAO Rice Probiotics Sunscreen ZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATE Guangdong Aimu Biological Technology Co., Ltd 4ccaa734-83c1-611b-e063-6294a90ab3bf 2026-03-21 Warnings Exact identifier application number: M020 Vacation Lip Trips Desserts Pineapple Upside Down Cake AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Vacation Inc. 69022828-8226-4977-a2ca-ad8e16793a59 2026-03-20 Warnings Exact identifier application number: M020 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Vacation Inc. c7794831-52d1-4d80-936d-44af18ae0472 2026-03-20 Warnings Exact identifier application number: M020 YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen ZINC OXIDE CA-Botana International 4d74a36c-ff68-afd9-e063-6394a90a08f8 2026-03-20 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE 468d4ed2-e616-aaaf-e063-6294a90af37a 2026-03-20 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c500e58f-38b0-454e-8923-912844276b17 2026-03-20 Warnings Exact identifier application number: M020 Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZER TITANIUM DIOXIDE, ZINC OXIDE HEALTHY SKIN LAB LIMITED 4a1ec566-549f-45f2-a43d-dacfc7263361 2026-03-20 Warnings Exact identifier application number: M020 SOJO sunscreen ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d44efb6-abc5-c346-e063-6394a90a6023 2026-03-19 Warnings Exact identifier application number: M020 VRC Lip balm SPF15 ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d588fbe-e61a-2264-e063-6394a90aa060 2026-03-19 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 54111-146-50 54111014650 1 TUBE in 1 BOX (54111-146-50) / 148 mL in 1 TUBE 1 tube 2019-11-06 0000-00-00 No No Current