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 267 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cay Skin Isle Glow Face SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.d91bba06-fd9b-3eb5-e053-2995a90a61242024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc65de9491-8804-4e3b-90a7-9b253e34b7d32024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc499e5352-fcc4-4434-96f2-4375816991c92024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Sheen Sunstick SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECay Skin, Inc.288c3aeb-01b2-ce39-e063-6394a90ad04a2024-12-05WarningsExact identifier
application number: M020
Cay Skin MoBay Mineral Sunscreen Drops SPF 30ZINC OXIDECay Skin, Inc.288d5456-98f3-a998-e063-6294a90a83662024-12-05WarningsExact identifier
application number: M020
Solar Moisturizer SPF 30OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENEAllure Labs, LLCef4d54bf-25f5-4261-9d3d-c42b0d8922752024-12-05WarningsExact identifier
application number: M020
Clear Clear Zinc Solar Protection SPF 30ZINC OXIDEAllure Labs, LLC79a3c8e2-c4f2-4c00-8e94-494654ae91a22024-12-05WarningsExact identifier
application number: M020
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONEAramis Inc.8b206b6d-92e4-48bc-a40c-93ffdd6355352024-12-05WarningsExact identifier
application number: M020
Kids Broad Spectrum SPF 35ZINC OXIDEAllure Labs, LLCb72caf9b-46df-f30c-e053-2995a90a9b6d2024-12-05WarningsExact identifier
application number: M020
CBD Blue Light Defense SPF 30ZINC OXIDEAllure Labsb63b99af-2ddb-3535-e053-2a95a90a65d52024-12-05WarningsExact identifier
application number: M020
AHAVA CC SPF 30AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd2fa6249a-9614-455c-8e07-9b829f3b0c222024-12-04WarningsExact identifier
application number: M020
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 21ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9585d3d2-806c-36e3-e053-2a95a90a28fa2024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No21OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3d196cf3-eddd-21d7-e054-00144ff88e882024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 23ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.6a81522e-f4d9-4013-8563-f50f01ff63262024-12-04WarningsExact identifier
application number: M020
Milani Prime Protect SPF 30 Face PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONEThe Milani Group, Inc.d557d554-5161-482c-bd78-7721c7dc9a6e2024-12-04WarningsExact 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