FDA.reportPublic FDA data

COOLA Classic Body Sunscreen Tropical Coconut

Product NDC
79753-076
11-digit product format
797530076
Labeler code
79753
Product ID
79753-076_a0a84e34-88b1-43ef-9dc6-d375e69d71c2
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
2023-02-01
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
15; 37.5; 22.5; 17.5 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 Body Sunscreen Tropical Coconut
Brand name suffix
SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE15 mg/mL
OCTOCRYLENE37.5 mg/mL
HOMOSALATE22.5 mg/mL
AVOBENZONE17.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55ad5d2f-a855-491e-a287-13689f8abff1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-076-01COOLA Classic Body Sunscreen Tropical CoconutSPF 30148 mL in 1 TUBELOTION1482
79753-076-01COOLA Classic Body Sunscreen Tropical CoconutSPF 301 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-076COOLA CLASSIC BODY SUNSCREEN TROPICAL COCONUT SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA LLC]2Current NDC, 2 package rows20241228_55ad5d2f-a855-491e-a287-13689f8abff1.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 175 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEDEWYTREE CO. ,LTD2f1ca6e0-f689-57c7-e063-6394a90a3da52025-10-21WarningsExact identifier
application number: M020
TOSOWOONG Rice Glow SunScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMANTONG Co., Ltd.3e9120fd-1c2f-1546-e063-6394a90a9e462025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - BuffHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.857666da-2b4a-4a4a-aa25-ed6fd9b6a1632025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V62031860-2e28-4b25-82bd-29b874b24d842025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - CocoaHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.40e6473a-8363-4503-bde0-6c151296fb342025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Golden TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7f4a185c-85c7-43bf-8695-c01a3aecec0d2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - NaturalHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V383aabdf-3feb-4407-9d85-27c11cb3e78c2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - ShellHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V4585b1c8-e477-44d7-a3ad-a9efc3d699b72025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Soft IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V1e9efb61-06ad-4d2d-a81d-46aba72f75142025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- BisqueHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.Vffc421e1-26eb-44e7-b03c-5fab761a51b22025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V3617d26e-a94c-4665-988b-95dbbc5270172025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- HoneyHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.55be05c0-429a-4ae0-bb86-1120bb1905ff2025-10-21WarningsExact identifier
application number: M020
Sun face protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e1ced7-dafa-c71e-e053-2995a90a95502025-10-21WarningsExact identifier
application number: M020
Jafra Sun sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b9316e16-c571-4a5c-e053-2995a90ac6a82025-10-21WarningsExact identifier
application number: M020
Jafra Sun tinted face protector sunscreen broad spectrum 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8df67f8-57d9-ddc1-e053-2995a90a50c62025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC0b625d48-9632-0464-e063-6394a90a9adc2025-10-21WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
application number: M020
UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC4198cfc0-a696-e279-e063-6294a90ac2392025-10-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79753-076-01797530076011 TUBE in 1 CARTON (79753-076-01) / 148 mL in 1 TUBE1 tube2023-02-01NoNoCurrent