Coola Anti-aging Sun Silk Drops Sunscreen Spf 30

Coola Anti-aging Sun Silk Drops Sunscreen Spf 30
SPL v1
SPL
SPL Set ID bbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c2
Route
TOPICAL
Published
Effective Date 2025-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Ethylhexyl Salicylate (4.0 g) Octocrylene (8.0 g)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Butyloctyl Salicylate Polyglyceryl-6 Stearate Glycerin Carthamus Tinctorius (safflower) Seed Oil Rubus Idaeus (raspberry) Seed Oil Simmondsia Chinensis (jojoba) Seed Oil Cocoa Schinus Molle Oil Blainvillea Acmella Flowering Top Jasminum Sambac (jasmine) Flower Oil Sodium Hyaluronate Ethyl Ferulate Water Butylene Glycol 1,2-hexanediol Caprylyl Glycol Glyceryl Stearate Hydroxyacetophenone Polyglyceryl-6 Behenate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Sodium Phytate .alpha.-tocopherol Acetate Astragalus Mongholicus Root Sodium Hydroxide Ubiquinone Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Active Ingredients AVOBENZONE 3.0%, OCTISALATE 4.0%, OCTOCRYLENE 8.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

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 aging caused by the sun

Dosage and Administration

Directions

● Shake well ● Apply liberally 15 minutes before sun

exposure ● Reapply:  ● After swimming or sweating

● 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-sleve shirts, pants, hats, and sunglasses

● Children under 6 months: Ask a doctor

Description

Active Ingredients AVOBENZONE 3.0%, OCTISALATE 4.0%, OCTOCRYLENE 8.0%

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 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

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Butyloctyl

Salicylate, Polyglyceryl-6 Stearate, Glycerin

(ORGANIC), Carthamus Tinctorius (Safflower) Seed

Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil

(ORGANIC), Simmondsia Chinensis (Jojoba) Seed

Oil (ORGANIC), Theobroma Cacao (Cocoa) Seed

Extract, Schinus Molle Extract, Spilanthes Acmella

Flower/Leaf/Stem Extrqact, Jasminum Sambac

(Jasmine) Leaf Cell Extract, Sodium Hyaluronate,

Ethyl Ferulate, Water, Butylene Glycol,

1,2-Hexanediol, Caprylyl Glycol, Glyceryl Stearate,

Hydroxyacetophenone, Polyglyceryl-6 Behenate,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Sodium Phytate, Tocopheryl Acetate, Astragalus

Membranaceus Root Extract, Sodium Hydroxide,

Ubiquinone, Propanediol, Fragrance* (Natural)

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose  

Sunscreen

Section 55106-9

Active Ingredients

AVOBENZONE 3.0%, OCTISALATE 4.0%, OCTOCRYLENE 8.0%

Section 60561-8

Other Information

Protect this product from excessive heat and direct sun

Product Labeling:  Coola Anti Aging Sun Silk Drops Sunscreen Spf 30

COOLA

Anti-Aging

Sun Silk Drops

Sunscreen

30

1.0 FL OZ / 30 mL

©2024 COOLA. Manufactured in the USA for COOLA LLC,

located in Sunny San Diego, CA 92009.

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 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

● 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-sleve shirts, pants, hats, and sunglasses

● Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

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)

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Butyloctyl

Salicylate, Polyglyceryl-6 Stearate, Glycerin

(ORGANIC), Carthamus Tinctorius (Safflower) Seed

Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil

(ORGANIC), Simmondsia Chinensis (Jojoba) Seed

Oil (ORGANIC), Theobroma Cacao (Cocoa) Seed

Extract, Schinus Molle Extract, Spilanthes Acmella

Flower/Leaf/Stem Extrqact, Jasminum Sambac

(Jasmine) Leaf Cell Extract, Sodium Hyaluronate,

Ethyl Ferulate, Water, Butylene Glycol,

1,2-Hexanediol, Caprylyl Glycol, Glyceryl Stearate,

Hydroxyacetophenone, Polyglyceryl-6 Behenate,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Sodium Phytate, Tocopheryl Acetate, Astragalus

Membranaceus Root Extract, Sodium Hydroxide,

Ubiquinone, Propanediol, Fragrance* (Natural)

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose  

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

AVOBENZONE 3.0%, OCTISALATE 4.0%, OCTOCRYLENE 8.0%

Section 60561-8 (60561-8)

Other Information

Protect this product from excessive heat and direct sun

Product Labeling:  Coola Anti Aging Sun Silk Drops Sunscreen Spf 30 (Product Labeling:  COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30)

COOLA

Anti-Aging

Sun Silk Drops

Sunscreen

30

1.0 FL OZ / 30 mL

©2024 COOLA. Manufactured in the USA for COOLA LLC,

located in Sunny San Diego, CA 92009.

All Rights Reserved.

www.coola.com

CARTON

BOTTLE

res


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