FDA.reportPublic FDA data

COOLA Classic Body SPF 50 Guava Mango

Product NDC
79753-059
Requested package NDC
79753-059-01
11-digit product format
797530059
Labeler code
79753
Product ID
79753-059_2e21acbd-4362-923b-e063-6394a90a3269
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-01
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active strength
2.9; 4.9; 9.5; 4 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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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 SPF 50 Guava Mango
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.9 g/100mL
OCTISALATE4.9 g/100mL
OCTOCRYLENE9.5 g/100mL
HOMOSALATE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed13afaa-35ec-8326-e053-2995a90adaf0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
79753-059-012025-02-14Coola Classic Body Spray SPF 50 - Guava Mango
79753-059-022025-02-14Coola Classic Body Spray SPF 50 - Guava Mango
79753-059-012024-01-30Coola Classic Body Spray SPF 50 - Guava Mango
79753-059-022024-01-30Coola Classic Body Spray SPF 50 - Guava Mango

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-059-01COOLA Classic Body SPF 50 Guava Mango177 mL in 1 CANSPRAY1773
79753-059-02COOLA Classic Body SPF 50 Guava Mango60 mL in 1 CANSPRAY603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-059COOLA CLASSIC BODY SPF 50 GUAVA MANGO (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [COOLA, LLC]3Current NDC, Legacy NDC, 2 package rows20250216_ed13afaa-35ec-8326-e053-2995a90adaf0.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 325 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aacafca-baf7-9a22-e063-6394a90a2ca92023-11-21WarningsExact identifier
application number: M020
SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aad5ced-f356-e294-e063-6394a90aa8d52023-11-21WarningsExact identifier
application number: M020
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0aaeaf00-a438-8164-e063-6394a90a88362023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0ab169df-a760-8978-e063-6394a90ac2f42023-11-21WarningsExact identifier
application number: M020
Sun X SPF 50 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMCoreTex Products, INCc0355990-b842-47cd-e053-2a95a90a7c822023-11-20WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0a9b61ac-4f48-8399-e063-6394a90a43fe2023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Zinc Oxide Sunscreen Broad Spectrum SPF 50ZINC OXIDERite Aid0a9c37b1-6df3-37c6-e063-6394a90ac8c32023-11-20WarningsExact identifier
application number: M020
SPF 15 Lip and SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.0b385246-dc77-6874-e063-6394a90a59592023-11-20WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
application number: M020
Banana Boat Sport coolzone Clear Sunscreen Broad Spectrum SPF 50 PlusAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCab84b94b-8e04-605f-e053-2a95a90a8e342023-11-16WarningsExact identifier
application number: M020
Alba Botanica Maximum Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc02ba8b03-a1fc-608f-e063-6394a90a06a82023-11-16WarningsExact identifier
application number: M020
Alba Botanica Hawaiian SPF 50 CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf693699d-716c-af7f-e053-2a95a90af11a2023-11-16WarningsExact identifier
application number: M020
Alba Botanica Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc.fd78fb8e-99b0-91b0-e053-6394a90a92712023-11-16WarningsExact identifier
application number: M020
Alba Botanica Kids SPF 50 Tropical FruitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf6941bab-1e97-1dc8-e053-2995a90a93172023-11-16WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE HOMOSALATE OCTOCRYLENEEdgewell Personal Care Brands, LLC0fc83618-9a6d-5ad1-e054-00144ff88e882023-11-16WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a4cea12-7e00-d201-e063-6394a90a66912023-11-16WarningsExact identifier
application number: M020
SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCfb841fd7-0c78-01a1-e053-6394a90a43822023-11-15WarningsExact identifier
application number: M020
Banana Boat Kids Sport Sunscreen Roll-On UVA/UVB Broad Spectrum SPF 60 PlusAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7563a84-f622-dad6-e053-2a95a90aa8d92023-11-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-059-0179753005901177 mL in 1 CAN (79753-059-01) 177 ml2019-10-010000-00-00NoNoCurrent