FDA.reportPublic FDA data

COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush

Manufacturer
COOLA, LLC
Effective date
2024-02-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:15

Label at a glance#

ProductCOOLA Mineral Liplux Lip Balm SPF 30 Summer Crush
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 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 with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pant...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.6%

Zinc Oxide 3.0%

OTC - PURPOSE SECTION

Sunscreen

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 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 with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

Acacia Decurrens Flower Wax, Butyrospermum Parkii (ORGANIC Shea Butter), C18-38 Alkyl Hydroxystearoyl
Stearate, Caesalpinia Sappan Bark Extract, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax,
Flavor, Helianthus Annuus (ORGANIC Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Castor Oil,
Iron Oxides, Jojoba Esters, Mica, Octyldodecyl Oleate, Octyldodecyl PCA, Olea Europaea (ORGANIC Olive) Fruit Oil, Persea
Gratissima (ORGANIC Avocado) Oil, Polyglycerin-3, Polyhydroxystearic Acid, Red Lake 7, Rosmarinus Officinalis (ORGANIC
Rosemary) Leaf Extract, Schinziophyton Rautanenii Kernel Oil (ORGANIC), Silica, Stevia Rebaudiana Extract, Theobroma Cacao
(ORGANIC Cocoa) Seed Butter, Theobroma Grandiflorum Seed Butter (ORGANIC), Tin Oxide, Triethoxycaprylsilane

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-05779753-057-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
SCHINZIOPHYTON RAUTANENII SEED OIL6GSJ7A6T1EIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
STANNIC OXIDEKM7N50LOS6IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
OLIVE OIL6UYK2W1W1EIACT
D&C RED NO. 7ECW0LZ41X8IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
OCTYLDODECYL PCAE25TY46YTDIACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIB
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
AVOCADO OIL6VNO72PFC1IACT
COCOA BUTTER512OYT1CRRIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
CAESALPINIA SAPPAN BARKR6995U1QSXIACT
MICAV8A1AW0880IACT
ROSEMARYIJ67X351P9IACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
SUNFLOWER OIL3W1JG795YIIACT
C18-38 ALKYL HYDROXYSTEAROYL STEARATEWW4FVB2PEMIACT
STEVIA REBAUDIANA WHOLE6U422Y08O2IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
ndc (package): 79753-057-01
ndc (product): 79753-057
ndc11 (package): 79753005701
spl id: 106b77f6-5900-2120-e063-6294a90af8d0
spl set id: edc6754e-dabb-5bff-e053-2a95a90a7390

Reported adverse events (FAERS/openFDA)#

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