Coola Refreshing Water Mist Sunscreen Spf 18

Coola Refreshing Water Mist Sunscreen Spf 18
SPL v1
SPL
SPL Set ID 627d6472-c637-431d-bde2-556b531a13ff
Route
TOPICAL
Published
Effective Date 2023-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.0 g) Homosalate (10.0 g) Octisalate (5.0 g) Octocrylene (5.5 g)
Inactive Ingredients
Aloe Vera Leaf Undecane Tridecane Water Coconut Water Hyaluronate Sodium Jasminum Officinale Leaf Cocoa Schinus Molle Fruiting Top Piperonal Juniperus Deppeana Wood Oil Propanediol Butylene Glycol Methylpropanediol Medium-chain Triglycerides Caprylyl Glycol Polyquaternium-80 Phytate Sodium Didecyldimonium Chloride P-anisaldehyde Benzyl Acetate .delta.-decalactone .gamma.-nonalactone .gamma.-octalactone Methyl Benzoate Nerolidol Ethyl Butyrate Triethyl Citrate Vanillin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-02-01

Description

Drug Facts Active Ingredients Avobenzone 2.0%. Homosalate 10.0% Octisalate 5.0%, Octocrylene 5.5%


Medication Information

Warnings and Precautions

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

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

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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor



Description

Drug Facts Active Ingredients Avobenzone 2.0%. Homosalate 10.0% Octisalate 5.0%, Octocrylene 5.5%

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 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Extract (ORGANIC), Undecane,

Tridecane, Water, Cocos Nucifera (Coconut) Water

(ORGANIC), Sodium Hyaluronate, Jasminum Sambac

(Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa)

Seed Extract, Schinus Molle Extract, Heliotropine*,

Juniperus Mexicana*, Propanediol, Butylene Glycol,

Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl

Glycol, Polyquaternium-80, Sodium Phytate,

Didecyldimonium Chloride, Anisaldehyde*, Benzyl

acetate*, Delta-Decalactone*, Gamma-Nonalactone*,

Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl

Butyrate*, Triethyl citrate*, Vanillin

* Plant-derived scent constituent.

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Drug Facts

Active Ingredients

Avobenzone 2.0%. Homosalate 10.0%

Octisalate 5.0%, Octocrylene 5.5%

Section 60561-8

Other information

• protect this product from excessive heat and direct sun

Product Label Coola Refreshing Water Mist Sunscreen Spf 18

SPF

18

COOLA​®

Refreshing Water Mist

Sunscreen

Broad Spectrum SPF 18

0.85 FL OZ / 25 mL

© 2022 COOLA. Manufactured in the USA for

COOLA LLC, located inSunny & Cool San

Diego, CA 92009.  All Rights Reserved.

www.coola.com

Carton

Jar

 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 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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor



Warnings and Precautions (34071-1)

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

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 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Extract (ORGANIC), Undecane,

Tridecane, Water, Cocos Nucifera (Coconut) Water

(ORGANIC), Sodium Hyaluronate, Jasminum Sambac

(Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa)

Seed Extract, Schinus Molle Extract, Heliotropine*,

Juniperus Mexicana*, Propanediol, Butylene Glycol,

Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl

Glycol, Polyquaternium-80, Sodium Phytate,

Didecyldimonium Chloride, Anisaldehyde*, Benzyl

acetate*, Delta-Decalactone*, Gamma-Nonalactone*,

Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl

Butyrate*, Triethyl citrate*, Vanillin

* Plant-derived scent constituent.

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Avobenzone 2.0%. Homosalate 10.0%

Octisalate 5.0%, Octocrylene 5.5%

Section 60561-8 (60561-8)

Other information

• protect this product from excessive heat and direct sun

Product Label Coola Refreshing Water Mist Sunscreen Spf 18 (Product Label - COOLA Refreshing Water Mist Sunscreen SPF 18)

SPF

18

COOLA​®

Refreshing Water Mist

Sunscreen

Broad Spectrum SPF 18

0.85 FL OZ / 25 mL

© 2022 COOLA. Manufactured in the USA for

COOLA LLC, located inSunny & Cool San

Diego, CA 92009.  All Rights Reserved.

www.coola.com

Carton

Jar

 res


Advanced Ingredient Data


Raw Label Data

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