Coola Sun Silk Drops Spf 30

Coola Sun Silk Drops Spf 30
SPL v2
SPL
SPL Set ID c0c07144-2e32-4a61-a516-bcf44dd04812
Route
TOPICAL
Published
Effective Date 2021-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Octisalate (4.0 g) Octocrylene (8.0 g)
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate Glycerin Polyglyceryl-6 Stearate Safflower Seed Oil Polyglyceryl-6 Esters Olive Oil Jojoba Oil Cocoa Jasminum Sambac Flower Schinus Molle Fruiting Top Hyaluronate Sodium Sodium Hydroxide Arthrospira Platensis Water Ethyl Ferulate Propanediol Butylene Glycol 1,2-hexanediol Caprylyl Glycol Glyceryl Monostearate Hydroxyacetophenone Polyglyceryl-6 Behenate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Phytate Sodium .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-09-01

Description

Drug Facts Active Ingredients Avobenzone 3%, Octisalate 4%, Octocrylene 8%


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

● shake well ● 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 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 3%, Octisalate 4%, Octocrylene 8%

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),

Butyloctyl Salicylate, Glycerin (ORGANIC),

Polyglyceryl-6 Stearate, Carthamus Tinctorius

(Safflower) Seed Oil (ORGANIC), Olea Europaea

(Olive) Fruit Oil (ORGANIC), Simmondsia Chinensis

(Jojoba) Seed Oil (ORGANIC), Theobroma Cacao

(Cocoa) Seed Extract, Jasminum Sambac

(Jasmine) Leaf Cell Extract, Schinus Molle Extract,

Sodium Hyaluronate, Sodium Hydroxide, Plankton

Extract, Water, Ethyl Ferulate, Propanediol,

Butylene Glycol, 1,2-Hexanedipol, Caprylyl Glycol,

Glyceryl Stearate, Hydroxyacetophenone,

Polyglyceryl-6 Behenate, Acrylates/10-30 Alkyl

Acrylate Crosspolymer, Sodium Phylae,

Tocopheryl Acetate, 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 3%, Octisalate 4%, Octocrylene 8%

Section 60561-8

Other information

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

SPF

30

70%+

Organic

COOLA​®

Sun Silk Drops

Sunscreen

1.0 FL OZ / 30 mL

*SPF value may decrease if blended.

For detailed instructions, see insert.

©2021 COOLA. Distributed by: COOLA LLC,

located in Sunny & Cool San Diego, CA 92010. 

All Rights Reserved. 

www.coola.com

Carton

Bottle

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 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 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),

Butyloctyl Salicylate, Glycerin (ORGANIC),

Polyglyceryl-6 Stearate, Carthamus Tinctorius

(Safflower) Seed Oil (ORGANIC), Olea Europaea

(Olive) Fruit Oil (ORGANIC), Simmondsia Chinensis

(Jojoba) Seed Oil (ORGANIC), Theobroma Cacao

(Cocoa) Seed Extract, Jasminum Sambac

(Jasmine) Leaf Cell Extract, Schinus Molle Extract,

Sodium Hyaluronate, Sodium Hydroxide, Plankton

Extract, Water, Ethyl Ferulate, Propanediol,

Butylene Glycol, 1,2-Hexanedipol, Caprylyl Glycol,

Glyceryl Stearate, Hydroxyacetophenone,

Polyglyceryl-6 Behenate, Acrylates/10-30 Alkyl

Acrylate Crosspolymer, Sodium Phylae,

Tocopheryl Acetate, 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 3%, Octisalate 4%, Octocrylene 8%

Section 60561-8 (60561-8)

Other information

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

SPF

30

70%+

Organic

COOLA​®

Sun Silk Drops

Sunscreen

1.0 FL OZ / 30 mL

*SPF value may decrease if blended.

For detailed instructions, see insert.

©2021 COOLA. Distributed by: COOLA LLC,

located in Sunny & Cool San Diego, CA 92010. 

All Rights Reserved. 

www.coola.com

Carton

Bottle

res


Advanced Ingredient Data


Raw Label Data

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