Coola Classic Body Spray Spf 50 - Unscented

Coola Classic Body Spray Spf 50 - Unscented
SPL v3
SPL
SPL Set ID ed207afe-0b10-74c7-e053-2a95a90a9b87
Route
TOPICAL
Published
Effective Date 2022-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.9 g) Octisalate (4.9 g) Octocrylene (9.5 g) Homosalate (4.3 g)
Inactive Ingredients
Opuntia Ficus-indica Flower Vinyl Acetate Dibutyl Maleate Isobornyl Acrylate Ethyl Ferulate Brassica Rapa Subsp. Oleifera Oil Camelina Sativa Seed Oil Alcohol Butyloctyl Salicylate Safflower Oil Meadowfoam Seed Oil Mauritia Flexuosa Fruit Oil Raspberry Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-01

Description

Avobenzone - 2.9% Homosalate - 4.3% Octisalate - 4.9% Octocrylene - 9.5%


Medication Information

Warnings and Precautions
  • For external use only
  • Flammable: Contents under pressure. Do not puncture or incinerat. Do not store at temperatures above 120 F. Do not use in the presence of a flame or spark, or while smoking.
  • Do not use on damaged or broken skin.
  • When using this product keep away from face to avoid breathing. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-ventilated area.
  • Stop use and ask a doctor if rash occurs.
Description

Avobenzone - 2.9% Homosalate - 4.3% Octisalate - 4.9% Octocrylene - 9.5%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the nsk of skin cancer and early skin aging caused by the sun
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 51727-6

Alcohol (ORGANIC), Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate

Section 51945-4

Section 53413-1

Call 760-940-2125

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone - 2.9%

Homosalate - 4.3%

Octisalate - 4.9%

Octocrylene - 9.5%

Section 60561-8
  • May stain fabrics
  • Protect this product from excessive heat and direct sun
Directions
  • Shake Well
  • Apply liberally 15 minutes before sun exposure.
  • Hold container 4 to 6 inches from skin to apply.
  • Rub in. Do not spray directly on face.
  • Spray onto hands and apply to face.
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses.​
  • Children under six months: Ask a doctor.

Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the nsk of skin cancer and early skin aging caused by the sun
Warnings and Precautions (34071-1)
  • For external use only
  • Flammable: Contents under pressure. Do not puncture or incinerat. Do not store at temperatures above 120 F. Do not use in the presence of a flame or spark, or while smoking.
  • Do not use on damaged or broken skin.
  • When using this product keep away from face to avoid breathing. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-ventilated area.
  • Stop use and ask a doctor if rash occurs.
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 51727-6 (51727-6)

Alcohol (ORGANIC), Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 760-940-2125

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone - 2.9%

Homosalate - 4.3%

Octisalate - 4.9%

Octocrylene - 9.5%

Section 60561-8 (60561-8)
  • May stain fabrics
  • Protect this product from excessive heat and direct sun
Directions
  • Shake Well
  • Apply liberally 15 minutes before sun exposure.
  • Hold container 4 to 6 inches from skin to apply.
  • Rub in. Do not spray directly on face.
  • Spray onto hands and apply to face.
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses.​
  • Children under six months: Ask a doctor.

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