FDA.reportPublic FDA data

COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush

Product NDC
79753-057
11-digit product format
797530057
Labeler code
79753
Product ID
79753-057_106b77f6-5900-2120-e063-6294a90af8d0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
3.6; 3 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 Mineral Liplux Lip Balm SPF 30 Summer Crush
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE3.6 g/100g
ZINC OXIDE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
edc6754e-dabb-5bff-e053-2a95a90a7390Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-057-01COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush4.2 g in 1 TUBESTICK4.24
79753-057-01COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush1 in 1 CARTONSTICK14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-057COOLA MINERAL LIPLUX LIP BALM SPF 30 SUMMER CRUSH (ZINC OXIDE) STICK [COOLA, LLC]4Current NDC, Legacy NDC, 2 package rows20240203_edc6754e-dabb-5bff-e053-2a95a90a7390.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 140 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e7e6-b301-136d-e063-6294a90aba182025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e4fa-883b-fb9c-e063-6394a90adcc42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483dd31-417b-01ba-e063-6294a90a83a82025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e998-6122-fb84-e063-6394a90a159f2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c96e691a-99e1-4cb4-aebf-7444f4a6865f2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ab1c8e9e-fd8f-473e-8930-625706e8e9d62025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.17073264-ec02-4801-841d-86778debd8c42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.caee5c88-1907-41c1-987e-5bc544267dca2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.973b70f1-ee59-4dd9-aca3-432d721204ab2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.208fe03e-384b-4599-a4d0-a553fba306da2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.279258dd-b3fa-47be-8540-66bd9c879fc52025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.4206b607-5c26-4c9d-ade7-58c9740cdbe82025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beauty949a2796-717c-4820-ae09-2636e3dd6e3d2025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium DarkOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyf9bbc6d3-eb50-4953-8dba-732094b4c7c42025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD53df3126-1136-490a-b339-5876ce89499e2025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50 kidsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD3fa04557-2bc1-4eb4-aed8-eacc791896132025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 40OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENIDARIA TECHNOLOGY LTDc900b88b-1de1-4df9-af84-d9001e1d47642025-12-09WarningsExact identifier
application number: M020
StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.ed357e76-54a1-66bd-e053-2a95a90a1e2a2025-12-09WarningsExact identifier
application number: M020
Non-tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dd2f6b-5dcc-b081-e063-6394a90ae5f12025-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-057-01797530057011 TUBE in 1 CARTON (79753-057-01) / 4.2 g in 1 TUBE1 tube2019-02-010000-00-00NoNoCurrent