FDA.reportPublic FDA data

Liplux

Manufacturer
COOLA LLC
Effective date
2025-02-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:55:44

Label at a glance#

ProductLiplux SPF 30 Lip Balm
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating. Apply at least every 2 hours. Sun Protection Measures - to decrease your risk of cancer and early skin aging, regularly use a sunscreen wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, expecially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pain...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 7.6%

Purpose

OTC - PURPOSE SECTION

Sunscreens

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Stop use and ask doctor if skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating. Apply at least every 2 hours. Sun Protection Measures - to decrease your risk of cancer and early skin aging, regularly use a sunscreen wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, expecially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, paints, hats, and sunglasses. Children under 6 months: ask a doctor.

RECENT MAJOR CHANGES SECTION

correct spelling mistakes

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Euphorbia Cerifera (Candelilla) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Linoleic Acid, Persea Gratissima (Avocado) Oil (Organic), Phospholipids, Phytosterols, Polyhydroxstearic Acid, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Simmondsia Chinensis (Jojoba) Seed OIl (ORGANIC), Stevia Rebaudiana Extract, Tetrahexyldecyl Ascorbate, Theobroma Grandiflorum Seed Butter (ORGANIC), Tocopherol (ORGANIC)

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or Concerns?

OTC - QUESTIONS SECTION

Call 760-940-2125

Primary and secondary package labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tubetube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartonscartons

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79753-012-012025-02-20C16284748780-1f386c64a-39f1-0266-e053-dadaa90a7c1aCOOLA Classic Liplux Lip Balm SPF30 0.15oz - Original
79753-012-012023-01-30C16284748780-1f386c64a-39f1-0266-e053-dadaa90a7c1aCOOLA Classic Liplux Lip Balm SPF30 0.15oz - Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-012-01LipluxSPF 30 Lip Balm4.2 g in 1 TUBESTICK4.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-012LIPLUX SPF 30 LIP BALM (CLASSIC) STICK [COOLA LLC]2Current NDC, Legacy NDC, 1 package rows20250223_b47b5f3a-43f3-ae7a-e053-2995a90ae16d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-01279753-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
LINOLEIC ACID9KJL21T0QJIACT
SAFFLOWER OIL65UEH262ISIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ASTROCARYUM VULGARE KERNEL OIL1IQY04O559IACT
COCONUT OILQ9L0O73W7LIACT
BEHENYL BEHENATEK8NU647RJ0IACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
CANDELILLA WAXWL0328HX19IACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
AVOBENZONEG63QQF2NOXACTIB
CARNAUBA WAXR12CBM0EIZIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
AVOCADO OIL6VNO72PFC1IACT
ALOE VERA LEAFZY81Z83H0XIACT
REBAUDIOSIDE AB3FUD0528FIACT
JOJOBA OIL724GKU717MIACT
CASTOR OILD5340Y2I9GIACT
ROSEMARYIJ67X351P9IACT
ROSA CANINA FRUIT3TNW8D08V3IACT
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
RASPBERRY SEED OIL9S8867952AIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liplux SPF 30 Lip BalmCLASSICCOOLA LLCb47b5f3a-43f3-ae7a-e053-2995a90ae16d2025-02-17WarningsExact identifier
ndc (package): 79753-012-01
ndc (product): 79753-012
ndc11 (package): 79753001201
spl id: 2e57ccfc-f187-4dbe-e063-6394a90a2019
spl set id: b47b5f3a-43f3-ae7a-e053-2995a90ae16d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.