Coola Classic Sunscreen Stick Spf 30 - Tropical Coconut

Coola Classic Sunscreen Stick Spf 30 - Tropical Coconut
SPL v1
SPL
SPL Set ID d31e301a-e73a-4660-84b4-df4597638eb6
Route
TOPICAL
Published
Effective Date 2020-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Octisalate (4.0 g) Octocrylene (7.0 g)
Inactive Ingredients
1,2-hexanediol Levomenol Bis-octyldodecyl Dimer Dilinoleate/propanediol Copolymer Brassica Rapa Subsp. Oleifera Oil Camelina Sativa Seed Oil Camellia Oil Medium-chain Triglycerides Safflower Oil 2,6-dimethyl-5-heptenal .gamma.-nonalactone .gamma.-octalactone 10-hydroxystearic Acid Meadowfoam Seed Oil Maltol Mauritia Flexuosa Fruit Oil Opuntia Ficus-indica Leaf Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Raspberry Seed Oil Silica Dimethyl Silylate 2-hexenal, (2e)- Triethyl Citrate Vanillin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-08

Description

Drug Facts Active Ingredients Avobenzone 3.0%, Octisalate 4.0%, Octocrylene 7.0%


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.

Do not use on damaged or broken skin

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 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 spection

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 3.0%, Octisalate 4.0%, Octocrylene 7.0%

Section 42229-5

Questions or comments?

Call 760-940-2125

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

1,2-Hexanediol, Bisabolol, Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer,

Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Camellia Oleifera

Seed Oil (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Carthamus Tinctorius

(Safflower) Seed Oil (ORGANIC), Dimethyl Heptenal*, Gamma-Nonalactone*,

Gamma-Octalactone*, Hydroxystearic Acid, Limnanthes Alba (Meadowfoam) Seed Oil,

Maltol*, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract,

Polyester-8, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Silica Dimethyl Silylate,

Trans-2-Hexenal*, Triethyl Citrate*, VANILLIN* OR VANADIUM*???*

Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octisalate 4.0%, Octocrylene 7.0%

Section 60561-8

Other information

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

SPF

30

70%+

Organic

COOLA​®

Classic

Sunscreen Stick

Tropical Coconut

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

+Plant Protection®

0.6 OZ / 17.0 g

©2021 COOLA. Distributed by: COOLA LLC, located in Sunny &

Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.com

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

*Plant-derived scent constituent. See coola.com for additional detail.

Carton

Canister

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 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 spection

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.

Do not use on damaged or broken skin

Section 42229-5 (42229-5)

Questions or comments?

Call 760-940-2125

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

1,2-Hexanediol, Bisabolol, Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer,

Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Camellia Oleifera

Seed Oil (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Carthamus Tinctorius

(Safflower) Seed Oil (ORGANIC), Dimethyl Heptenal*, Gamma-Nonalactone*,

Gamma-Octalactone*, Hydroxystearic Acid, Limnanthes Alba (Meadowfoam) Seed Oil,

Maltol*, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract,

Polyester-8, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Silica Dimethyl Silylate,

Trans-2-Hexenal*, Triethyl Citrate*, VANILLIN* OR VANADIUM*???*

Section 55105-1 (55105-1)

Purpose

Suncreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octisalate 4.0%, Octocrylene 7.0%

Section 60561-8 (60561-8)

Other information

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

SPF

30

70%+

Organic

COOLA​®

Classic

Sunscreen Stick

Tropical Coconut

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

+Plant Protection®

0.6 OZ / 17.0 g

©2021 COOLA. Distributed by: COOLA LLC, located in Sunny &

Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.com

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

*Plant-derived scent constituent. See coola.com for additional detail.

Carton

Canister

res


Advanced Ingredient Data


Raw Label Data

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