coola mineral sunscreen stick spf 50

coola mineral sunscreen stick spf 50
SPL v5
SPL
SPL Set ID ee8706b0-ad42-403a-be7c-b660f040a244
Route
topical
Published
Effective Date 2022-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (13.63 g)
Inactive Ingredients
sunflower oil medium-chain triglycerides carnauba wax ceresin polymethylsilsesquioxane (11 microns) capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) silicon dioxide trimethoxybenzylidene pentanedione shea butter 1,2-hexanediol dimethicone ethyl ferulate triethoxycaprylylsilane polyhydroxystearic acid (2300 mw) meadowfoam seed oil mauritia flexuosa fruit oil raspberry seed oil opuntia ficus-indica whole

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-01-16

Description

Drug Facts Active Ingredients Zinc Oxide 13.63%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Active Ingredient

Drug Facts

Active Ingredients

Zinc Oxide 13.63%

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 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 Zinc Oxide 13.63%

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 doctorif skin rash occurs

Section 51727-6

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride

(ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite,

Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica,

Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC),

1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic

Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC),

Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC)

Section 53413-1

Questions or comments?

Call 760-940-2125

Section 55105-1

Purpose

Suncreen

Section 60561-8

Other information

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

SPF

50

70%+

Organic

COOLA ​®

Classic

Sunscreen Stick

Fragrance-Free

Broad Spectrum SPF 50

Water-Resistant (80 Minutes)

+Plant Protection ®

Net Wt. 0.6 OZ / 17.0 g

©2022 COOLA. Manufactured in the USA for COOLA, located in

Sunny & Cool San Diego, CA 92010.  All Rights Reserved.  Questions or

Comments?  Call 760-940-2125. www.coola.com

res


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Active Ingredient (55106-9)

Drug Facts

Active Ingredients

Zinc Oxide 13.63%

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 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

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 doctorif skin rash occurs

Section 51727-6 (51727-6)

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride

(ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite,

Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica,

Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC),

1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic

Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC),

Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC)

Section 53413-1 (53413-1)

Questions or comments?

Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Suncreen

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 ​®

Classic

Sunscreen Stick

Fragrance-Free

Broad Spectrum SPF 50

Water-Resistant (80 Minutes)

+Plant Protection ®

Net Wt. 0.6 OZ / 17.0 g

©2022 COOLA. Manufactured in the USA for COOLA, located in

Sunny & Cool San Diego, CA 92010.  All Rights Reserved.  Questions or

Comments?  Call 760-940-2125. www.coola.com

res


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