Coola Refreshing Water Hydration Stick Spf 50

Coola Refreshing Water Hydration Stick Spf 50
SPL v3
SPL
SPL Set ID 6da037f8-bedb-467a-b534-e44752120f2c
Route
TOPICAL
Published
Effective Date 2023-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Octisalate (2.15 g) Homosalate (3.5 g) Octocrylene (5.0 g)
Inactive Ingredients
Aloe Vera Leaf Glycerin Sodium Stearate Carthamus Tinctorius (safflower) Oleosomes Polyglyceryl-10 Caprylate Polyglyceryl-10 Caprate Butyloctyl Salicylate Carnauba Wax Sorbitan Olivate Vinylpyrrolidone/hexadecene Copolymer Propanediol Butylene Glycol 1,2-hexanediol Caprylyl Glycol Water Jasminum Officinale Leaf Azadirachta Indica Leaf Azadirachta Indica Flower Corallina Officinalis Coccinia Grandis Fruit Tropolone Eggplant Cocoa Aloe Vera Flower Coconut Water Jojoba Oil Turmeric Ocimum Basilicum Flowering Top Holy Basil Leaf Schinus Molle Fruiting Top Hyaluronic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-16

Description

Drug Facts Active Ingredients Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.15%, Octocrylene 5.0%


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.

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

●apply liberally 15 minutes before sun exposure.

● reapply: ●after swimming or sweating ● immediately afte

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 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

Drug Facts Active Ingredients Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.15%, Octocrylene 5.0%

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 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Glycerin (ORGANIC), Sodium Stearate, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Polyglyceryl-10 Caprylate/Caprate, Butyloctyl Salicylate, Copernicia Cerifera (Carnauba) Wax (ORGANIC), Sorbitan Olivate, VP/Hexadecene Copolymer, Cocos Nucifera (Coconut) Fruit Water (ORGANIC), Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coralline Officinalis Extract, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Aloe Barbadensis Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Hyaluronic Acid, Coccinia Indica Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus Molle Extract, Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Water, Tropolone, Fragrance (Natural)

Section 53413-1

Questions or comments?

Call 760-940-2125

Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.15%, Octocrylene 5.0%

Section 60561-8

Other information

  • may stain fabrics
  • protect this product from excessive heat and direct sun
Coola Label

SPF

50

70%+

Organic

COOLA​®

Refreshing Water

Hydration Stick

Sunscreen

Net Wt. 0.8 OZ / 22.0 g

©2023 COOLA. Manufactured in the USA for COOLA

LLC, located in Sunny & Cool San Diego, CA 92010. 

All Rights Reserved.  www.coola.com

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

●apply liberally 15 minutes before sun exposure.

● reapply: ●after swimming or sweating ● immediately afte

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 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

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.

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 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Glycerin (ORGANIC), Sodium Stearate, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Polyglyceryl-10 Caprylate/Caprate, Butyloctyl Salicylate, Copernicia Cerifera (Carnauba) Wax (ORGANIC), Sorbitan Olivate, VP/Hexadecene Copolymer, Cocos Nucifera (Coconut) Fruit Water (ORGANIC), Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coralline Officinalis Extract, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Aloe Barbadensis Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Hyaluronic Acid, Coccinia Indica Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus Molle Extract, Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Water, Tropolone, Fragrance (Natural)

Section 53413-1 (53413-1)

Questions or comments?

Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Suncreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.15%, Octocrylene 5.0%

Section 60561-8 (60561-8)

Other information

  • may stain fabrics
  • protect this product from excessive heat and direct sun
Coola Label (COOLA Label)

SPF

50

70%+

Organic

COOLA​®

Refreshing Water

Hydration Stick

Sunscreen

Net Wt. 0.8 OZ / 22.0 g

©2023 COOLA. Manufactured in the USA for COOLA

LLC, located in Sunny & Cool San Diego, CA 92010. 

All Rights Reserved.  www.coola.com

res


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