Coola Clear Sunscreen Spray Spf 50 6 Fl Oz - California Summers (01-dbm-105)

Coola Clear Sunscreen Spray Spf 50 6 Fl Oz - California Summers (01-dbm-105)
SPL v1
SPL
SPL Set ID 358009c4-492d-ac03-e063-6294a90af227
Route
TOPICAL
Published
Effective Date 2025-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (71.25 g) Homosalate (0.002 g) Avobenzone (1 g) Octisalate (4.8 g)
Inactive Ingredients
Alcohol Opuntia Ficus-indica Flower Monoisobutyl Maleate Butyloctyl Salicylate Rubus Idaeus (raspberry) Seed Oil Camelina Sativa Seed Oil Carthamus Tinctorius (safflower) Seed Oil Ethyl Ferulate Limnanthes Alba (meadowfoam) Seed Oil Brassica Campestris (rapeseed) Seed Oil Mauritia Flexuosa Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-19

Description

Active Ingredients Avobenzone 2.9%, Homosalate 4.0%, Octisalate 4.9%, Octocrylene 9.5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures about 120ºF. Do not use in the presence of a flame or spark, or while smoking.

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 skin aging caused by the sun

Dosage and Administration

Shake Well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. -Reapply: -After 80 minutes of swimming or sweating. -Immediately after towel drying. -At least every 2 hours.

-Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad specturm SPF of 15 or higher and other sun protection measures including: -Limit time in the sun, especially from: 10am - 2pm. -Wear long sleeve shirt, pants, hat and sunglasses -Children under 6 months; Ask a doctor

Description

Active Ingredients Avobenzone 2.9%, Homosalate 4.0%, Octisalate 4.9%, Octocrylene 9.5%

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 away from face to avoid breaking. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-venitilated area.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Alcohol (ORGANIC), Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuose (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate, Fragrance (Natural)

Section 51945-4

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose

Sunscreeen

Section 55106-9

Active Ingredients

Avobenzone 2.9%, Homosalate 4.0%, Octisalate 4.9%, Octocrylene 9.5%

Section 60561-8

Other Information -May stain fabrics -Protect this product from excessive heat and direct sun


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 skin aging caused by the sun

Dosage and Administration (34068-7)

Shake Well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. -Reapply: -After 80 minutes of swimming or sweating. -Immediately after towel drying. -At least every 2 hours.

-Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad specturm SPF of 15 or higher and other sun protection measures including: -Limit time in the sun, especially from: 10am - 2pm. -Wear long sleeve shirt, pants, hat and sunglasses -Children under 6 months; Ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures about 120ºF. Do not use in the presence of a flame or spark, or while smoking.

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 away from face to avoid breaking. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-venitilated area.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Alcohol (ORGANIC), Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuose (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate, Fragrance (Natural)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Sunscreeen

Section 55106-9 (55106-9)

Active Ingredients

Avobenzone 2.9%, Homosalate 4.0%, Octisalate 4.9%, Octocrylene 9.5%

Section 60561-8 (60561-8)

Other Information -May stain fabrics -Protect this product from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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