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 132 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373cef98-a61d-dd36-e063-6394a90a7c3b2025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373d1e6c-9c32-20f5-e063-6294a90af86f2025-12-11Exact identifier
application number: M020
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373ddad0-ed33-a233-e063-6294a90a19cd2025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37263083-b24f-5a71-e063-6294a90aee7d2025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37265b3d-92ef-ef4a-e063-6294a90a8d952025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373d902f-f7b6-298b-e063-6394a90a93072025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726c177-2912-a6cc-e063-6394a90a00432025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726f463-7e55-c2a2-e063-6394a90a3c512025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37617bd5-c275-aeee-e063-6394a90a214d2025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37644dfd-e96d-a783-e063-6294a90a97962025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3762f132-4ab0-74ad-e063-6394a90a436c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37637e45-c6ed-12ca-e063-6294a90aeb022025-12-11Exact identifier
application number: M020
Face and Body SunscreenZINC OXIDESCIENCE CEUTICALS, LLC369b42f3-5203-87c4-e063-6394a90a62842025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a32097-de93-9b1d-e063-6394a90a41df2025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37641f8b-0133-8bfc-e063-6294a90aac5c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3764856a-98c5-334e-e063-6394a90a629d2025-12-11Exact identifier
application number: M020
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a3e268-e376-11a0-e063-6294a90a46af2025-12-11Exact 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