FDA.reportPublic FDA data

Coola

Product NDC
79753-033
11-digit product format
797530033
Labeler code
79753
Product ID
79753-033_29b70f22-a6e1-4c0b-e063-6294a90a8d1d
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen Face Mist
Dosage form
SPRAY
Route
TOPICAL
Labeler
COOLA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-02
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2.9; 4.9; 9.5 g/100mL; g/100mL; g/100mL
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
Brand name suffix
SPF 50 Classic
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d18d0dac-5690-436e-e053-2995a90a0254Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79753-033-012023-04-04C16284748780-1f386c649-a0a0-0266-e053-dadaa90a7c1aCoola Classic Face Sunscreen Mist SPF 50 (07-OC-013)
79753-033-012023-01-30C16284748780-1f386c649-a0a0-0266-e053-dadaa90a7c1aCoola Classic Face Sunscreen Mist SPF 50 (07-OC-013)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-033-01CoolaSPF 50 Classic100 mL in 1 BOTTLE, PLASTICSPRAY1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-033COOLA SPF 50 CLASSIC (SUNSCREEN FACE MIST) SPRAY [COOLA LLC]3Current NDC, Legacy NDC, 1 package rows20241222_d18d0dac-5690-436e-e053-2995a90a0254.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 222 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halo Glow Skin Tint SPF 50 84507ZINC OXIDEe.l.f. Cosmetics, Inc.31314118-0fd6-5549-e063-6394a90a9d1f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84506ZINC OXIDEe.l.f. Cosmetics, Inc.313119be-c1f2-4cb0-e063-6294a90a03ca2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84516ZINC OXIDEe.l.f. Cosmetics, Inc.312dd439-5cc8-e034-e063-6394a90a5c762025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84504ZINC OXIDEe.l.f. Cosmetics, Inc.223efabb-d018-c337-e063-6394a90a56052025-03-25WarningsExact identifier
application number: M020
IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEIT COSMETICS, LLC9f8786cc-bef6-4449-8f31-dfc08de777342025-03-25WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30cce5b1-ed41-5bf2-e063-6394a90aaf1d2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30df95da-4868-1414-e063-6294a90acdac2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1bd3c-6a0b-a8f8-e063-6394a90acfb72025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1b4c9-0d77-b08a-e063-6394a90af6832025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1ff3f-0fd0-2880-e063-6294a90a462f2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e25241-0d2b-8c04-e063-6294a90a44b92025-03-24WarningsExact identifier
application number: M020
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY311ae6d6-d466-3f1d-e063-6294a90ab3dd2025-03-24WarningsExact identifier
application number: M020
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311de9db-941c-5af9-e063-6294a90a3a132025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311e6378-5afa-d7eb-e063-6394a90a77282025-03-24WarningsExact identifier
application number: M020
Naked Sundays Golden Glow Body Sunscreen SPF50 100mlNAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100MLNAKED SUNDAYS PTY LTDe182a39b-89b1-7756-e053-2a95a90ab6192025-03-23WarningsExact identifier
application number: M020
ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUMAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDeb7a84a8-3e25-9988-e053-2a95a90a58a92025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-033-0179753003301100 mL in 1 BOTTLE, PLASTIC (79753-033-01) 100 ml2021-11-020000-00-00NoNoCurrent