Coola Firming Face Serum Sunscreen Oil Spf 30

Coola Firming Face Serum Sunscreen Oil Spf 30
SPL v1
SPL
SPL Set ID 85fd7ef4-ed08-4a69-8293-5f3f3d264c04
Route
TOPICAL
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Homosalate (5.0 g) Ethylhexyl Salicylate (10.0 g) Octocrylene
Inactive Ingredients
Caprylic/capric Triglyceride Helianthus Annuus (sunflower) Seed Oil Ethylhexyl Methoxycrylene Soybean Oil Tetrahexyldecyl Ascorbate Bakuchiol Moringa Oleifera Seed Oil Simmondsia Chinensis (jojoba) Seed Oil Carthamus Tinctorius (safflower) Seed Oil Hippophae Rhamnoides Fruit Oil Alaria Esculenta Rosemary Citrullus Lanatus (watermelon) Seed Oil Tagetes Erecta Flower 1,2-hexanediol .alpha.-tocopherol Acetate Terpineol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Active Ingredients AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 5%, OCTOCRYLENE 10%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures

(see Directions) decreases the risk of skin cancer and

early aging caused by the sun

Dosage and Administration

Directions

● Apply liberally 15 minutes before sun exposure

● Reapply at least every 2 hours

● Use a water resistant sunscreen especially if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases

your risk of skin cancer and early aging. To decrease this

risk, regularly use a sunscreen with a broad spectrum SPF of 15

or higher and other sun protection measures including:



   ● Limit time in the sun, especially from: 10 a.m. – 2 p.m.

   ● Wear long-sleve shirts, pants, hats, and sunglasses

   ● Children under 6 months: Ask a doctor

Description

Active Ingredients AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 5%, OCTOCRYLENE 10%

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 50566-9

Stop use and ask doctor if skin rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive Ingredients

Caprylic/Capric Triglyceride(ORGANIC), Helianthus Annuus

(Sunflower) Seed Oil (ORGANIC), Ethylhexyl Methoxycrylene,

Maleated Soybean Oil Glyceryl/Octyldodecanol Esters

(ORGANIC), Tetrahexyldecyl Ascorbate, Bakuchiol, Moringa

Oleifera Seed Oil (ORGANIC), Simmondsia Chinensis

(Jojoba) Seed Oil (ORGANIC), Carthamus Tinctorius

(Safflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Alaria

Esculenta Extract, Rosmarinus Officinalis (Rosemary) Leaf

Extract, Citrullus Lanatus (Watermelon) Seed Oil, Tagetes

Erecta Flower Extract, 1,2-Hexanediol, Tocopheryl Acetate,

Terpineol, Fragrance* (Natural)

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose  

Sunscreen

Section 55106-9

Active Ingredients

AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 5%, OCTOCRYLENE 10%

Section 60561-8

Other Information

Protect this product from excessive heat and direct sun

Product Labeling - COOLA Firming Face Oil Sunscreen SPF 30

COOLA Firming Face Oil

Sunscreen

Broad Spectrum  SPF 30

1.1 FL OZ / 33 mL

2024 COOLA.

Manufactured in the USA for

COOLA LLC, located in Sunny

San Diego, CA 92009.

All Rights Reserved.

www.coola.com

33 mL Carton

33 mLBottle

5 mL Sample Card

5 mL Sample Bottle

res


Structured Label Content

Indications and Usage (34067-9)

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures

(see Directions) decreases the risk of skin cancer and

early aging caused by the sun

Dosage and Administration (34068-7)

Directions

● Apply liberally 15 minutes before sun exposure

● Reapply at least every 2 hours

● Use a water resistant sunscreen especially if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases

your risk of skin cancer and early aging. To decrease this

risk, regularly use a sunscreen with a broad spectrum SPF of 15

or higher and other sun protection measures including:



   ● Limit time in the sun, especially from: 10 a.m. – 2 p.m.

   ● Wear long-sleve shirts, pants, hats, and sunglasses

   ● Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

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 50566-9 (50566-9)

Stop use and ask doctor if skin rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredients

Caprylic/Capric Triglyceride(ORGANIC), Helianthus Annuus

(Sunflower) Seed Oil (ORGANIC), Ethylhexyl Methoxycrylene,

Maleated Soybean Oil Glyceryl/Octyldodecanol Esters

(ORGANIC), Tetrahexyldecyl Ascorbate, Bakuchiol, Moringa

Oleifera Seed Oil (ORGANIC), Simmondsia Chinensis

(Jojoba) Seed Oil (ORGANIC), Carthamus Tinctorius

(Safflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Alaria

Esculenta Extract, Rosmarinus Officinalis (Rosemary) Leaf

Extract, Citrullus Lanatus (Watermelon) Seed Oil, Tagetes

Erecta Flower Extract, 1,2-Hexanediol, Tocopheryl Acetate,

Terpineol, Fragrance* (Natural)

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose  

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 5%, OCTOCRYLENE 10%

Section 60561-8 (60561-8)

Other Information

Protect this product from excessive heat and direct sun

(-------------------)

Product Labeling - COOLA Firming Face Oil Sunscreen SPF 30

COOLA Firming Face Oil

Sunscreen

Broad Spectrum  SPF 30

1.1 FL OZ / 33 mL

2024 COOLA.

Manufactured in the USA for

COOLA LLC, located in Sunny

San Diego, CA 92009.

All Rights Reserved.

www.coola.com

33 mL Carton

33 mLBottle

5 mL Sample Card

5 mL Sample Bottle

res


Advanced Ingredient Data


Raw Label Data

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