COOLA CLASSIC SUNSCREEN FRAGRANCE FREE

Product NDC: 79753-045
11-digit product format: 797530045
Labeler code: 79753
Product ID: 79753-045_45ede361-ecc1-0474-e063-6294a90a9c2d
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: COOLA, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-01-01
Substance: HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength: 100; 30; 80; 45 mg/mL; mg/mL; mg/mL; mg/mL
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 CLASSIC SUNSCREEN FRAGRANCE FREE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	100 mg/mL
AVOBENZONE	30 mg/mL
OCTOCRYLENE	80 mg/mL
OCTISALATE	45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
4X49Y0596W	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
cfc21b1a-4a26-1573-e053-2995a90a2d50	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79753-045-72	COOLA CLASSIC SUNSCREEN FRAGRANCE FREE	946 mL in 1 BOTTLE	LOTION	946		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79753-045	COOLA CLASSIC SUNSCREEN FRAGRANCE FREE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241025_cfc21b1a-4a26-1573-e053-2995a90a2d50.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 276 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	20b32aae-7f8b-44ed-a3df-706054fd6883	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	d77be4d0-c08a-4d81-b5df-a9bae38e3b97	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN	HOMOSALATE, OCTISALATE	FRUIT OF THE EARTH, INC.	13325a2a-f7f8-4019-acbb-205fd5dd13a5	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	ae7951e9-54f6-4eab-81b6-a2b2c978851d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Clubwith Blood Orange and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7805f3c-5b95-73bd-e053-2a95a90a9984	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Manuka Honey and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7820ba9-7520-5139-e053-2a95a90ab92d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Blood Orange and Essential Oils SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7916317-c6a2-2eda-e053-2995a90a1628	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Mentha and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c790031d-5448-a998-e053-2a95a90a763e	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of The Earth Sun Town City Kids SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c79472ea-a367-1328-e053-2a95a90a22d5	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 Sunscreen	HOMOSALATE, OCTISALATE	Fruit of the Earth, Inc.	c7a94f68-a4d5-ec82-e053-2995a90a38fb	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7ba72c2-ea23-0bb9-e053-2a95a90a1d90	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c795cd2f-89dc-78e3-e053-2a95a90a9422	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7a4783f-477f-1524-e053-2995a90a5ad9	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 15 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7aaa185-8490-60ec-e053-2995a90adc0d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Dark Tanning SPF 8 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7aa1e58-f7b3-6b7f-e053-2995a90a957c	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7bbad46-5c52-9f1d-e053-2995a90ae139	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7bdd7a3-2e88-d881-e053-2a95a90a2ef9	2024-10-17	Warnings	Exact identifier application number: M020
dermalogica dynamic skin recovery spf 50	SUNSCREEN	Dermalogica, LLC	051b77ab-6970-48e4-bbfd-c066178ea32e	2024-10-17	Warnings	Exact identifier application number: M020
Hyaluronic Moisturizer	OCTINOXATE, OXYBENZONE. AVOBENZONE	Bentley Laboratories LLC	88bd6dff-ba19-4f8f-9432-28398d24f1ab	2024-10-16	Warnings	Exact identifier application number: M020
EQUALINE SPORT CONTINUOUS SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	United Natural Foods, Inc. dba UNFI	f13feba4-25d8-61d0-e053-2995a90aafa8	2024-10-16	Warnings	Exact identifier application number: M020

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79753-045-72	79753004572	946 mL in 1 BOTTLE (79753-045-72)	946 ml	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COOLA CLASSIC SUNSCREEN LOTION FRAGRANCE-FREE	COOLA, LLC \| Bentley Laboratories, LLC	2025-12-14	HUMAN OTC DRUG LABEL	4