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 61 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.c76f5639-bd0f-4987-8c70-224ee33bbbad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.8795b9a7-1938-4dd9-92ad-3c044feae1da2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f8bad95-8071-47b1-88a7-3a3f09f097b52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEBETTER INNOVATION LTD4b9a881a-835b-ef0c-e063-6394a90a94af2026-02-24WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE MOISTURIZER SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a9303-662f-9614-e063-6294a90a6b512026-02-24WarningsExact identifier
application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4b9ac780-ef7d-42fc-e063-6394a90ad62f2026-02-24WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4b9b36a6-4da9-8439-e063-6394a90aa86b2026-02-24WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
application number: M020
cle de peau BEAUTE ADVANCED PROTECTIVE DAYAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation710975d8-43bf-40b9-82c2-d4dc2988956d2026-02-23WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
application number: M020
Eryfotona AgelessZINC OXIDEISDIN Corp.a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f2026-02-23WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDEMeijer, Inc.69b72139-757f-476d-99d2-33f5524c41d22026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
daily moisturizerAVBENZONE, OCTISALATE, OCTOCRYLENEMeijer, Inc.6d301146-46e0-445c-b14e-3ec8ce76cb452026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.e9f4a2bb-d21e-4b38-9a37-23c23c8ad8572026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut ScentAVOBENZONE, OCTISALATE, OCTOCRYLENEInk-eeze3f759bec-4e33-46fa-a800-fa3a17d63df92026-02-19WarningsExact identifier
application number: M020
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
application number: M020
e.l.f. Best and Obsessed Skincare SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.4b1c1150-5ac5-4a8b-e063-6394a90a54102026-02-18WarningsExact identifier
application number: M020
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
application number: M020
Degree ClinicalCOOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANTConopco Inc. d/b/a/ Unilever4b1f9fd3-3c49-9a98-e063-6294a90a20e02026-02-18WarningsExact 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