Coola Classic Body Sunscreen Spf 70 - Peach Blossom

Coola Classic Body Sunscreen Spf 70 - Peach Blossom
SPL v2
SPL
SPL Set ID 6efa0d9f-0ff3-4b2f-9587-9630261bcbd1
Route
TOPICAL
Published
Effective Date 2020-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Homosalate (5.0 g) Octisalate (4.9 g) Octocrylene (7.5 g)
Inactive Ingredients
1,2-hexanediol Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Aloe Vera Leaf Benzyl Alcohol Levomenol Brassica Rapa Subsp. Oleifera Oil Butyloctyl Salicylate Camelina Sativa Seed Oil Caprylyl Glycol Carthamus Tinctorius (safflower) Oleosomes Safflower Oil Citric Acid Monohydrate Coconut Oil Decanal 2,6-dimethyl-5-heptenal Ethyl Acetoacetate Ethyl Butyrate Ethyl Caproate .gamma.-nonalactone .gamma.-undecalactone Gluconolactone Glycerin Hexenyl Acetate, (2z)- Hexyl Acetate Hydroxyacetophenone Isoamyl Acetate Meadowfoam Seed Oil Mauritia Flexuosa Fruit Oil Opuntia Ficus-indica Leaf Pentylene Glycol Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Prunus Persica Flower 4-(p-hydroxyphenyl)-2-butanone Raspberry Seed Oil Sodium Benzoate Sodium Hydroxide Phytate Sodium Triethyl Citrate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-08

Description

Drug Facts Active Ingredients Avobenzone 3.0%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%


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%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%

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, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice (ORGANIC), Benzyl Alcohol, Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butyloctyl Salicylate, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Citric Acid, Cocos Nucifera (Coconut) Oil*, Decanal*, Dimethyl Heptenal*, Ethyl Acetoacetate*, Ethyl Butyrate*, Ethyl Caproate*, Gamma-Nonalactone*, Gamma Undecalactone*, Gluconolactone, Glycerin (ORGANIC), Hexenyl Acetate*, Hexyl Acetate*, Hydroxyacetophenone, Isoamyl Acetate*, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Opuntia Ficus-Indica Flower Extract, Pentylene Glycol, Polyacrylate Crosspolymer-6, Prunus Persica (Peach) Flower Extract, Raspberry Ketone*, Rubus Idaeus (Raspberry) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate*, Xanthan Gum

Section 53413-1

Questions or comments?

Call 760-940-2125

Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%

Section 60561-8

Other information

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

SPF

70

70%+

Organic

COOLA​®

Classic

Body Sunscreen

Peach Blossom

Ultra Lightweight

Hydrates & Nourishes

+Plant Protection®

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

5.0 FL OZ / 148 mL

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

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

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

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

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

• 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 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, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice (ORGANIC), Benzyl Alcohol, Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butyloctyl Salicylate, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Citric Acid, Cocos Nucifera (Coconut) Oil*, Decanal*, Dimethyl Heptenal*, Ethyl Acetoacetate*, Ethyl Butyrate*, Ethyl Caproate*, Gamma-Nonalactone*, Gamma Undecalactone*, Gluconolactone, Glycerin (ORGANIC), Hexenyl Acetate*, Hexyl Acetate*, Hydroxyacetophenone, Isoamyl Acetate*, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Opuntia Ficus-Indica Flower Extract, Pentylene Glycol, Polyacrylate Crosspolymer-6, Prunus Persica (Peach) Flower Extract, Raspberry Ketone*, Rubus Idaeus (Raspberry) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate*, Xanthan Gum

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 3.0%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%

Section 60561-8 (60561-8)

Other information

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

SPF

70

70%+

Organic

COOLA​®

Classic

Body Sunscreen

Peach Blossom

Ultra Lightweight

Hydrates & Nourishes

+Plant Protection®

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

5.0 FL OZ / 148 mL

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

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

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

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

Carton

Bottle

res


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