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 220 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
natural lip balm SPF15( Peppermint) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31548583-ecc7-2e1e-e063-6394a90a24022025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( strawberry) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3154b0f0-2025-4514-e063-6394a90a70c42025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Tropical Punch FlavoredLIP BALM SPF15 TROPICAL PUNCH FLAVOREDLS Promotions Inc3154ae45-e075-f53b-e063-6294a90aed5b2025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Passion Fruit flavoredLIP BALM SPF15 PASSION FRUIT FLAVOREDLS Promotions Inc31552e96-980c-8120-e063-6294a90af3da2025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( tropical punch) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.315579e7-e1fb-d6f5-e063-6294a90af06a2025-03-27WarningsExact identifier
application number: M020
Shea MoistureNOURISHED AND RADIANT BROAD SPECTRUM SPF 30 SUNSCREEN FACE LOTIONConopco d/b/a/ Unilever3159be1c-9678-5b1a-e063-6294a90acd082025-03-27WarningsExact identifier
application number: M020
CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc7d9e8c07-d295-4c8e-a52f-bdb509dc489b2025-03-27WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Mattifying Oil plus Pore Control SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC8d89ebf5-bcd5-4fde-a7d4-059023e00f332025-03-27WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Brightening SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC4ff8525a-4526-4acf-86c7-88f1f10732742025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 UnflavoredLIP BALM SPF15LS Promotions Inc3131632d-735c-6688-e063-6294a90a02392025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Chocolate Sundae flavoredLIP BALM SPF15LS Promotions Inc3142f352-ee65-47b5-e063-6394a90ada572025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Pina Colada flavoredLIP BALM SPF15 PINA COLADA FLAVOREDLS Promotions Inc31440153-e7ca-1327-e063-6294a90a562c2025-03-26WarningsExact identifier
application number: M020
CVS Health Sport 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY0a245b1b-eaf6-7011-e063-6294a90ab68f2025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Apple Pie flavoredLIP BALM SPF15 APPLE PIE FLAVOREDLS Promotions Inc3145bd6d-0ece-e9d5-e063-6294a90afb9d2025-03-26WarningsExact identifier
application number: M020
HEB Glow 40 Tinted Sunscreen Face PrimerAVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.B.3146bcd9-d562-9ba6-e063-6294a90a37aa2025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.3146fb5f-1fb5-f09f-e063-6294a90a62062025-03-26WarningsExact identifier
application number: M020
HEB 50 Glow Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.31473cc9-08f5-39e3-e063-6294a90aa4992025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.314776a8-a562-3dd2-e063-6394a90ab1b92025-03-26WarningsExact identifier
application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company31478f5a-88f4-4b01-e063-6394a90a04b72025-03-26WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company3147c08f-c3f2-aef1-e063-6294a90a5c442025-03-26WarningsExact 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