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 184 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Kids mineral STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEThe Natural SKN Company400c67aa-55a6-67ea-e063-6294a90a02132025-09-30WarningsExact identifier
application number: M020
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
application number: M020
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCcdc54f23-0efb-2fb4-e053-2995a90ae58b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLCb10a7794-7e4f-412b-9eb2-773107ecb7fc2025-09-26WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Black Girl Sunscreenfed22570-e0ae-43e1-b6ce-1f0ad01684c32025-09-26WarningsExact identifier
application number: M020
Sun Glazed SPF 30 Sunscreen Glow OilAVOBENZONE, HOMOSALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.3fa41ed1-2f7f-18e6-e063-6294a90a0a8b2025-09-25WarningsExact identifier
application number: M020
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
application number: M020
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVEAVOBENZONE, HOMOSALATE, OCTISALATEMDSolarSciences3fa810b0-0211-f2a7-e063-6294a90a0b722025-09-25WarningsExact identifier
application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50ZINC OXIDEHYGIENELAB, INC7db103da-b434-433a-a18f-a727165640c02025-09-24WarningsExact identifier
application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENESpace Brands Limited0e2c9ffb-036d-49c5-abdb-2ee8888df3182025-09-24WarningsExact 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