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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57f2fdeb-2abc-4ad3-bb89-5faee883c0e5	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54111-145-51	2023-01-06	C162847	48780-1	d6a99b39-6d3f-a426-e053-dadaa90af4c2	COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50
54111-145-51	2022-01-28	C162847	48780-1	d6a99b39-6d3f-a426-e053-dadaa90af4c2	COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50

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 106 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TAN	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	85f3dd47-4f1f-4fa3-a171-4f4b7707191c	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	4e5764f3-9d9e-460b-ab1e-36f280281dec	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	e700dc6e-e7ae-47ee-9974-430bfd045b4f	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TAN	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	c7924d60-03fb-4a4d-b718-e324f6f1f65f	2025-12-19	Warnings	Exact identifier application number: M020
THE GOLDEN GUARD Browning Radiance Gel Suncare for Body	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	4654c417-faa3-23c6-e063-6394a90a2b5a	2025-12-19	Warnings	Exact identifier application number: M020
THE MINERAL MELT Invisible Mineral Suncare for Face	TITANIUM DIOXIDE, ZINC OXIDE	Dune Suncare, Inc.	46557319-7546-e712-e063-6394a90a3cfe	2025-12-19	Warnings	Exact identifier application number: M020
Sand Cloud Mineral Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Sand Cloud Holdings, LLC	ff477199-9b01-fc90-e053-6294a90a5102	2025-12-19	Warnings	Exact identifier application number: M020
Sand Cloud Mineral Sunscreen For Face	TITANIUM DIOXIDE AND ZINC OXIDE	Sand Cloud Holdings, LLC	ff2346c6-d911-87b3-e053-6394a90ac6f8	2025-12-19	Warnings	Exact identifier application number: M020
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - Shell	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	12c63195-8707-4df0-a4d3-6f31c543db7a	2025-12-19	Warnings	Exact identifier application number: M020
EltaMD UV SPF35	OCTINOXATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	3029d6ed-a60b-4789-a567-d09b12d76bf4	2025-12-19	Warnings	Exact identifier application number: M020
OUHOE Universal Colored Moisturizer	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4634fdcd-6f0e-25ca-e063-6294a90a196e	2025-12-18	Warnings	Exact identifier application number: M020
SUNSCREEN SPRAY150mL	ZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%	Foshan Sugar Max Cosmetics CO.,Ltd	4635f90a-bbc9-0676-e063-6394a90a9f35	2025-12-18	Warnings	Exact identifier application number: M020
Sunscreen Stick	HOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	4637503c-46dc-68de-e063-6394a90abdc7	2025-12-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e78c9ae0-c2ef-12ce-e053-2995a90abf1c	2025-12-18	Warnings	Exact identifier application number: M020
NARS PURE RADIANT TINTED MOISTURIZER Cuzco	OCTINOXATE, TITANIUM DIOXIDE	NARS Cosmetics	5bb5d035-16d9-4843-b9aa-d30730c88508	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	248be719-edff-f40d-e063-6394a90a4ef6	2025-12-18	Warnings	Exact identifier application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	59187729-c166-58fe-e053-2991aa0abe47	2025-12-18	Warnings	Exact identifier application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	Laboratoires Dermo-Cosmetik Inc.	4f0d44ca-09f0-4feb-b78c-77d83e75d4e2	2025-12-18	Warnings	Exact identifier application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	60a304b1-eee5-408b-e053-2a91aa0a0a08	2025-12-18	Warnings	Exact identifier application number: M020
THE BOD GUARD Invisible Gel Sunscreen for Body	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	463fa1ef-d40d-d818-e063-6294a90a5e61	2025-12-18	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50	Bentley Laboratories, LLC	2023-12-19	HUMAN OTC DRUG LABEL	6