FDA.reportPublic FDA data

COOLA Classic Liplux Lip Balm SPF 30 Tinted

Product NDC
79753-019
11-digit product format
797530019
Labeler code
79753
Product ID
79753-019_2e947974-f005-ecaa-e063-6294a90ad877
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-01
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
7.6; 4.9; 2.9 g/100g; g/100g; g/100g
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 Liplux Lip Balm SPF 30 Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE7.6 g/100g
OCTISALATE4.9 g/100g
AVOBENZONE2.9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eec6e7c8-17fe-f34b-e053-2995a90a78a0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-019-01COOLA Classic Liplux Lip Balm SPF 30 Tinted4.2 g in 1 TUBESTICK4.26
79753-019-01COOLA Classic Liplux Lip Balm SPF 30 Tinted1 in 1 CARTONSTICK16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-019COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED (AVOBENZONE, OCTISALATE, OCTOCRYLENE) STICK [COOLA, LLC]6Current NDC, Legacy NDC, 2 package rows20250223_eec6e7c8-17fe-f34b-e053-2995a90a78a0.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 283 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vanicream Facial Moisturizer Broad Spectrum SPF30ZINC OXIDEPharmaceutical Specialties Incd8c9a8d0-1f24-2240-e053-2a95a90a8dee2024-10-15WarningsExact identifier
application number: M020
Mula Maldives SPF 30 Moisturizing SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEMula Maldives PVT LTDf9be092f-8d53-4bb2-8363-81c003da42d62024-10-15WarningsExact identifier
application number: M020
Kroger Invisible Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf71ee1cd-e075-9ee9-e053-6394a90a8f9f2024-10-15WarningsExact identifier
application number: M020
Kroger Sunscreen Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76e12aa-9d98-5694-e053-6294a90a52562024-10-15WarningsExact identifier
application number: M020
Kroger Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATETHE KROGER COMPANYf0f350f4-b1b9-f4d3-e053-2995a90ac4592024-10-15WarningsExact identifier
application number: M020
Kroger Shimmer Sunscreen Hydrating SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76fe840-0da2-a903-e053-6294a90a05ee2024-10-15WarningsExact identifier
application number: M020
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact identifier
application number: M020
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-019-01797530019011 TUBE in 1 CARTON (79753-019-01) / 4.2 g in 1 TUBE1 tube2021-07-010000-00-00NoNoCurrent