FDA.reportPublic FDA data

COOLA BARE REPUBLIC CLEARSCREEN SPF100

Product NDC
79753-021
11-digit product format
797530021
Labeler code
79753
Product ID
79753-021_46069245-ad40-caf7-e063-6394a90ab0c9
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
2021-10-21
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
150; 30; 100; 50 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 BARE REPUBLIC CLEARSCREEN SPF100
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE150 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE100 mg/mL
OCTISALATE50 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
f14cf2b8-b110-1210-e053-2995a90a0102Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-021-01COOLA BARE REPUBLIC CLEARSCREEN SPF10059 mL in 1 TUBELOTION593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-021COOLA BARE REPUBLIC CLEARSCREEN SPF100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC]2Current NDC, Legacy NDC, 1 package rows20241025_f14cf2b8-b110-1210-e053-2995a90a0102.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 279 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef FriendlyAVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONETHE KROGER COMPANYc706aaf0-a978-7848-e053-2995a90a0aca2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCc51029f4-ede0-08ef-e053-2995a90aecaf2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE,TOPCO ASSOCIATES LLCc8af028e-9d68-4023-e053-2995a90ad18a2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc5601d22-2353-7319-e053-2a95a90a16c02024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc8c12a5a-59f5-6515-e053-2995a90a58f72024-10-15WarningsExact identifier
application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc6268778-8dcc-24b6-e053-2995a90acf032024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf0de2999-f12b-89b1-e053-2a95a90ac6102024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50ZINC OXIDETOPCO ASSOCIATES LLCd501a94e-3bcd-d8e4-e053-2a95a90a33b02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Kids Mineral SunscreenZINC OXIDETOPCO ASSOCIATES LLCdbee42c8-9cae-7a81-e053-2a95a90a23292024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf12c09b1-8ffe-4933-e053-2995a90a434f2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30ZINC OXIDETOPCO ASSOCIATES LLCdbf03882-ab1a-9805-e053-2995a90a71092024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETOPCO ASSOCIATES LLCf14f43e6-ee57-5495-e053-2a95a90a40112024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCf31ea60e-1f52-c55f-e053-2a95a90afe642024-10-15WarningsExact identifier
application number: M020
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30ZINC OXIDETOPCO ASSOCIATES LLCf71e019b-392a-f8eb-e053-6394a90a871e2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultra Protection Sun SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf41d4c46-7998-afe6-e053-2995a90ab3612024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Mineral Sunscreen StickZINC OXIDEH.E.B.f58f0199-bf22-2197-e053-2995a90ae64f2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry ScentedZINC OXIDEH.E.B.f58d328c-8b30-b4d4-e053-2a95a90adb592024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-021-017975300210159 mL in 1 TUBE (79753-021-01) 59 ml2021-10-210000-00-00NoNoCurrent