Coola Classic Liplux Lip Balm Spf30 0.15oz - Original

Coola Classic Liplux Lip Balm Spf30 0.15oz - Original
SPL v2
SPL
SPL Set ID b47b5f3a-43f3-ae7a-e053-2995a90ae16d
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (8 g) Avobenzone (3 g)
Inactive Ingredients
Linoleic Acid Safflower Oil Astrocaryum Vulgare Kernel Oil Coconut Oil Behenyl Behenate Polyhydroxystearic Acid Stearate Candelilla Wax Theobroma Grandiflorum Seed Butter Carnauba Wax Sunflower Oil Tocopherol Avocado Oil Aloe Vera Leaf Rebaudioside A Jojoba Oil Castor Oil Rosemary Rosa Canina Fruit Levomenol Medium-chain Triglycerides Butyloctyl Salicylate Raspberry Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

Description

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 7.6%

Purpose

Sunscreens


Medication Information

Purpose

Sunscreens

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 43683-2

correct spelling mistakes

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 51945-4

Warnings

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.

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 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.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 7.6%

Inactive Ingredients

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)

Questions Or Concerns?

Call 760-940-2125

Primary and Secondary Package Labels


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.

Section 43683-2 (43683-2)

correct spelling mistakes

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 51945-4 (51945-4)

Purpose

Sunscreens

Warnings

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.

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 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.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 7.6%

Inactive Ingredients (Inactive ingredients)

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)

Questions Or Concerns? (Questions or Concerns?)

Call 760-940-2125

Primary and Secondary Package Labels (Primary and secondary package labels)


Advanced Ingredient Data


Raw Label Data

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