Coola Classic Face Sunscreen Mist Spf 50 (07-oc-013)

Coola Classic Face Sunscreen Mist Spf 50 (07-oc-013)
SPL v3
SPL
SPL Set ID d18d0dac-5690-436e-e053-2995a90a0254
Route
TOPICAL
Published
Effective Date 2021-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.9 g) Octisalate (4.9 g) Octocrylene (9.5 g)
Inactive Ingredients
Alcohol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Safflower Oil Ethylhexyl Methoxycrylene Vinyl Acetate Isobornyl Acrylate Dibutyl Maleate Camelina Sativa Seed Oil Dicapryl Succinate Brassica Rapa Subsp. Oleifera Oil Green Tea Leaf Mauritia Flexuosa Fruit Oil Levomenol Ethyl Ferulate Meadowfoam Seed Oil Opuntia Ficus-indica Flower Raspberry Seed Oil Glycyrrhiza Glabra Water Glycerin Butyloctyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-02

Description

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%

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

Warnings

For external use only.

Flammable: Do not store at temperatures above 120 F.

Do not use in the presence of a flame or spark, or while smoking.

Do not use on damaged or broken skin.

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

Stop use and ask doctor if skin rash occurs.

.

Directions

SHAKE WELL before use.

With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.

Wait until dry.

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes 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 the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:

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

-Wear long sleeves shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Package Label

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%

Inactive Ingredients

Alcohol (ORGANIC), Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Polyester-8, Fragrance (Natural), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Brassica Campestris (Rapeseed) Seed Oil, Camellia Sinensis Leaf Extract (ORGANIC),Glycyrrhiza Glabra (Licorice) Root Extract (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Bisabolol (ORGANIC), Glycerin (ORGANIC), Water, Ethyl Ferulate, Diisooctyl Succinate

Questions Or Comments

Call 760-940-2125


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 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

Purpose

Sunscreen

Warnings

For external use only.

Flammable: Do not store at temperatures above 120 F.

Do not use in the presence of a flame or spark, or while smoking.

Do not use on damaged or broken skin.

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

Stop use and ask doctor if skin rash occurs.

.

Directions

SHAKE WELL before use.

With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.

Wait until dry.

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes 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 the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:

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

-Wear long sleeves shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Package Label

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%

Inactive Ingredients

Alcohol (ORGANIC), Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Polyester-8, Fragrance (Natural), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Brassica Campestris (Rapeseed) Seed Oil, Camellia Sinensis Leaf Extract (ORGANIC),Glycyrrhiza Glabra (Licorice) Root Extract (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Bisabolol (ORGANIC), Glycerin (ORGANIC), Water, Ethyl Ferulate, Diisooctyl Succinate

Questions Or Comments (Questions or Comments)

Call 760-940-2125


Advanced Ingredient Data


Raw Label Data

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