Coola Full Spectrum 360 Sun Silk Drops Spf 30

Coola Full Spectrum 360 Sun Silk Drops Spf 30
SPL v1
SPL
SPL Set ID 9a03c1f7-098e-035d-e053-2a95a90a1fef
Route
TOPICAL
Published
Effective Date 2018-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (60 mg)
Inactive Ingredients
Water Alpha-tocopherol Acetate Sodium Stearoyl Glutamate Hyaluronate Sodium Sodium Benzoate Propanediol Olive Oil Gluconolactone Aloe Vera Leaf Cocoa Schinus Molle Fruiting Top Jasminum Sambac Flower Glyceryl Stearate Se Citrus Aurantium Flower Oil Safflower Oil Nylon-12 Butyloctyl Salicylate Chamaemelum Nobile Flower Oil Xanthan Gum Jojoba Oil Glycerin Dicaprylyl Carbonate Medium-chain Triglycerides Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-12-20

Description

Active ingredients Avobenzone 2.0%, Homosalate 10.0% Octisalate 5.0%, Octocrylene 6.0%


Medication Information

Indications and Usage

Uses

* helps prevent sunburn

* if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun

Dosage and Administration

Directions

* shake well * apply liberally
15 minutes before sun exposure

* reapply: * after 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 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-sleeve shirts, pants, hats, and sunglasses

* children under 6 months: Ask a doctor

Description

Active ingredients Avobenzone 2.0%, Homosalate 10.0% Octisalate 5.0%, Octocrylene 6.0%

Section 43685-7

Warnings

For external use only

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

Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

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

Aloe Barbadensis Leaf Extract (Organic), Anthemis Nobilis (Chamomile) Flower Oil, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Organic Safflower) Seed Oil, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Extract, Dicaprylyl Carbonate, Glycerin (Organic), Glyceryl Stearate Se, Jasminum Sambac (Jasmine) Leaf Cell Extract, Nylon-12, Olea Europaea (Organic Olive) Fruit Oil, Plankton Leaf Extract, Propanediol, Schinus Molle Extract, Simmondsia Chinensis (Organic Jojoba) Seed Oil, Sodium Benzoate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

Section 51945-4

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose

Sunscreen

Section 59845-8

How to use:

Apply daily to cleansed skin. For best

results, dispense several drops as needed

into palm of hand and apply evenly across

face and neck using upward strokes. Drops

are perfect for use alone or blended with

your everyday skincare and makeup.

Section 60561-8

Other information

* protect this product from excessive heat and direct sun

Drug Facts

Active ingredients

Avobenzone 2.0%, Homosalate 10.0%

Octisalate 5.0%, Octocrylene 6.0%


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 rise of skin cancer and early skin aging caused by the sun

Dosage and Administration (34068-7)

Directions

* shake well * apply liberally
15 minutes before sun exposure

* reapply: * after 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 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-sleeve shirts, pants, hats, and sunglasses

* children under 6 months: Ask a doctor

Section 43685-7 (43685-7)

Warnings

For external use only

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

Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

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)

Aloe Barbadensis Leaf Extract (Organic), Anthemis Nobilis (Chamomile) Flower Oil, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Organic Safflower) Seed Oil, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Extract, Dicaprylyl Carbonate, Glycerin (Organic), Glyceryl Stearate Se, Jasminum Sambac (Jasmine) Leaf Cell Extract, Nylon-12, Olea Europaea (Organic Olive) Fruit Oil, Plankton Leaf Extract, Propanediol, Schinus Molle Extract, Simmondsia Chinensis (Organic Jojoba) Seed Oil, Sodium Benzoate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 59845-8 (59845-8)

How to use:

Apply daily to cleansed skin. For best

results, dispense several drops as needed

into palm of hand and apply evenly across

face and neck using upward strokes. Drops

are perfect for use alone or blended with

your everyday skincare and makeup.

Section 60561-8 (60561-8)

Other information

* protect this product from excessive heat and direct sun

Drug Facts (DRUG FACTS)

Active ingredients

Avobenzone 2.0%, Homosalate 10.0%

Octisalate 5.0%, Octocrylene 6.0%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)