Coola Classic Liplux Lip Balm Spf 30 - Original

Coola Classic Liplux Lip Balm Spf 30 - Original
SPL v3
SPL
SPL Set ID eeb420f0-c92f-0d96-e053-2a95a90afe36
Route
TOPICAL
Published
Effective Date 2022-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.9 g) Avobenzone (2.9 g) Octocrylene (7.6 g)
Inactive Ingredients
Linoleic Acid Aloe Vera Leaf Behenyl Behenate Carnauba Wax Candelilla Wax Castor Oil Levomenol Avocado Oil Sunflower Oil Theobroma Grandiflorum Seed Butter Coconut Oil Jojoba Oil Astrocaryum Vulgare Kernel Oil Raspberry Seed Oil Soy Sterol Rosemary Medium-chain Triglycerides Lecithin, Soybean Tetrahexyldecyl Ascorbate Safflower Oil Stevia Rebaudiuna Leaf Butyloctyl Salicylate Polyhydroxystearic Acid (2300 Mw) Rosa Canina Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01
Description

Avobenzone – 2.9% Octisalate – 4.9% Octocrylene – 7.6%

Medication Information

Warnings and Precautions
  • 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
Description

Avobenzone – 2.9% Octisalate – 4.9% Octocrylene – 7.6%

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.
Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 53413-1

Call 760-940-2125

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone – 2.9%

Octisalate – 4.9%

Octocrylene – 7.6%

Section 60561-8

Protect this product from excessive heat and direct sun. May stain fabrics.

Directions
  • 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.

Structured Label Content

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.
Warnings and Precautions (34071-1)
  • 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
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 760-940-2125

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone – 2.9%

Octisalate – 4.9%

Octocrylene – 7.6%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun. May stain fabrics.

Directions
  • 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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.145984 · Updated: 2026-03-14T23:02:59.869199