FDA.reportPublic FDA data

COOLA CLASSIC SUNSCREEN FRAGRANCE FREE

Product NDC
79753-045
11-digit product format
797530045
Labeler code
79753
Product ID
79753-045_45ede361-ecc1-0474-e063-6294a90a9c2d
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
100; 30; 80; 45 mg/mL; mg/mL; mg/mL; mg/mL
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 CLASSIC SUNSCREEN FRAGRANCE FREE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE80 mg/mL
OCTISALATE45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfc21b1a-4a26-1573-e053-2995a90a2d50Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-045-72COOLA CLASSIC SUNSCREEN FRAGRANCE FREE946 mL in 1 BOTTLELOTION9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-045COOLA CLASSIC SUNSCREEN FRAGRANCE FREE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC]3Current NDC, Legacy NDC, 1 package rows20241025_cfc21b1a-4a26-1573-e053-2995a90a2d50.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 235 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunceutical SPF 50 Mineral Glow SerumZINC OXIDEBaxter Laboratories Pty. Ltd.2c2c9b67-9588-efbe-e063-6294a90aa6a42025-01-20WarningsExact identifier
application number: M020
JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.Vf627ab5b-85d4-4c92-9412-4bab72828f3d2025-01-17WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
application number: M020
Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50MINERAL SUNSCREENThe Center Brands, LLCcd35ae20-d5b7-479d-8a5e-0278eae9e83c2025-01-17WarningsExact identifier
application number: M020
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
application number: M020
Dolce and Gabbana Meet Your Flawless Matte Skin DuoOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDESocoplan3541c41b-f114-4734-a66f-be309ca6f3bf2025-01-16WarningsExact identifier
application number: M020
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
application number: M020
Snap On Racing Sunscreen KitAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGreater Pacific Industries, Inc.9f4f91d0-0fc5-43a3-be79-afce5afa2f952025-01-16WarningsExact identifier
application number: M020
Emme Diane Pure Protection Tinted Antioxidant SunscreenZINC OXIDEEmme Diane, Inc.b2b4daf5-765b-426d-8a72-9278f7cd43d72025-01-16WarningsExact identifier
application number: M020
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
application number: M020
Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40ZINC OXIDESUNNY SAILOR LLC14ea2d11-c425-45d8-a23a-d4ed82a6439c2025-01-15WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30GLO SKIN BEAUTY OIL-FREE TINTED PRIMER SPF 30Hayden Caleel LLC00bf7331-c9dc-4a8a-9ff3-901e0d07eac62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc42f6f-4eaf-fa28-e063-6294a90a93fb2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEBlack Girl Sunscreen, LLC2bc419b3-4de2-7ed9-e063-6394a90a255f2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc47bd0-d81b-f1b9-e063-6394a90ad3752025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50OCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONEBlack Girl Sunscreen, LLC2bc46854-fe67-782b-e063-6294a90a79af2025-01-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-045-7279753004572946 mL in 1 BOTTLE (79753-045-72) 946 ml2018-01-010000-00-00NoNoCurrent