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 193 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1f619e-dd4e-ab62-e063-6294a90a10d42025-08-22WarningsExact identifier
application number: M020
Sun Bum Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cf8c55b-5203-3a96-e063-6294a90a4e9e2025-08-22WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenZINC OXIDESun Bum LLC369f449f-fb9d-5529-e063-6394a90ac3b22025-08-22WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM FOUNDATION SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.2cb3cd01-8871-59a0-e063-6394a90ac0f72025-08-21WarningsExact identifier
application number: M020
Neutrogena Triple Age Repair Moisturizer with Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCa6011835-cd2f-476f-9ec1-721f896483c52025-08-21WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC35fc2571-370c-42aa-986c-b1fa58658d862025-08-21WarningsExact identifier
application number: M020
Sun Bum 50 Sunscreen Face StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3ce436e8-bc22-b9d7-e063-6394a90a57c42025-08-21WarningsExact identifier
application number: M020
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMYOCTINOXATE, ZINC OXIDEBEL STAR S Aea39a1c0-6b12-77ba-e053-2995a90a73142025-08-21WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCcd211d06-b91e-44b1-99fe-fa0794f102212025-08-21WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 KiwiAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cd51497-693e-bf79-e063-6394a90a5e482025-08-21WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.2f769ed5-0176-8c80-e063-6394a90a92c62025-08-21WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC21caf385-f11b-146a-e063-6294a90aa8512025-08-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3ce6d119-5e3e-dfa4-e063-6394a90a474b2025-08-21WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC21cb8652-c6d0-0a77-e063-6294a90a6e1e2025-08-21WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick 30ZINC OXIDESun Bum, LLC3ce81478-196e-d87b-e063-6294a90afd582025-08-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC33164cea-e31e-9fcc-e063-6294a90a307e2025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3ceb3368-439c-9f6c-e063-6294a90a98ba2025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cc8b151-c07d-7473-e063-6294a90a1cc72025-08-20WarningsExact 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