Coola Classic Liplux Lip Balm Spf 30 - Tinted

Coola Classic Liplux Lip Balm Spf 30 - Tinted
SPL v6
SPL
SPL Set ID eec6e7c8-17fe-f34b-e053-2995a90a78a0
Route
TOPICAL
Published
Effective Date 2022-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (7.6 g) Octisalate (4.9 g) Avobenzone (2.9 g)
Inactive Ingredients
Coconut Oil Jojoba Oil Astrocaryum Vulgare Kernel Oil Soy Sterol Stevia Rebaudiuna Leaf Rosemary Medium-chain Triglycerides Lecithin, Soybean Tetrahexyldecyl Ascorbate Safflower Oil Raspberry Seed Oil Octyldodecyl Oleate Calcium Aluminum Borosilicate Butyloctyl Salicylate Polyhydroxystearic Acid (2300 Mw) Rosa Canina Fruit Sweet Potato Maltodextrin Starch, Tapioca Citric Acid Monohydrate Acacia Radish Ferric Oxide Red Linoleic Acid Aloe Vera Leaf Behenyl Behenate Carnauba Wax Candelilla Wax Castor Oil Levomenol Avocado Oil Theobroma Grandiflorum Seed Butter Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01
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.
Carton

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), Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Tapioca Starch (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Polyhydroxystearic Acid, Titanium Dioxide, Maltodextrin, Flavor, Bisabolol (ORGANIC), Ipomoea Batatas Tuber Extract, Acacia Senegal Gum, Stevia Rebaudiana Extract, Octyldodecyl Oleate, Iron Oxides, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Citric Acid, Rosa Canina Fruit Extract (ORGANIC), Raphanus Sativus (Radish) Root Extract, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Tocopherol (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil, Linoleic Acid, Phospholipids, Phytosterols, Aloe Barbadensis Leaf Extract

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.
Carton

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), Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Tapioca Starch (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Polyhydroxystearic Acid, Titanium Dioxide, Maltodextrin, Flavor, Bisabolol (ORGANIC), Ipomoea Batatas Tuber Extract, Acacia Senegal Gum, Stevia Rebaudiana Extract, Octyldodecyl Oleate, Iron Oxides, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Citric Acid, Rosa Canina Fruit Extract (ORGANIC), Raphanus Sativus (Radish) Root Extract, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Tocopherol (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil, Linoleic Acid, Phospholipids, Phytosterols, Aloe Barbadensis Leaf Extract

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: 2026-02-15T12:05:36.213533 · Updated: 2026-03-14T23:07:39.601528