Coola Bare Republic Clearscreen Spf100 Non-aerosol Sunscreen Spray

Coola Bare Republic Clearscreen Spf100 Non-aerosol Sunscreen Spray
SPL v3
SPL
SPL Set ID f14d70f1-440b-900d-e053-2995a90a30a0
Route
TOPICAL
Published
Effective Date 2022-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Tridecyl Salicylate Butyloctyl Salicylate Glycerin Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Isodecyl Neopentanoate Alcohol Medium-chain Triglycerides Raspberry Seed Oil Lauryl Lactate Diisopropyl Sebacate Grape Seed Oil Carrot Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-23

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

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
Label

Warnings

​For external use only

Directions

• spray liberally and spread evenly 15 minutes before sun exposure



• hold can 4-6 inches away fromskin to apply



• do not spray into face. Spray into hand and apply to face.

  • Do not apply in windy conditions



• use in well ventilated, but not windy areas



reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months: Ask a doctor

  • 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

Do Not Use
  • on damaged or broken skin

Flammable:

• do not use near heat, flame or while smoking



• avoid long term storage above 104°F (40°C)

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients

SD Alcohol 40-B, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Octylacrylamide Copolymer, Diisopropyl Sebacate, Lauryl Lactate, Fragrance (Natural Fragrance), Caprylic/Capric Triglyceride, Glycerin, Rubus Idaeus (Red Raspberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil

When Using This Product

• keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

Keep Out of Reach of Children.

​If product is swallowed, get medical help or contact a Poison Control Center right away.

​stop Use and Ask Doctor If​
  • rash occurs.

Structured Label Content

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
Label

Purpose

Sunscreen

Warnings

​For external use only

Directions

• spray liberally and spread evenly 15 minutes before sun exposure



• hold can 4-6 inches away fromskin to apply



• do not spray into face. Spray into hand and apply to face.

  • Do not apply in windy conditions



• use in well ventilated, but not windy areas



reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months: Ask a doctor

  • 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

Do Not Use (Do not use)
  • on damaged or broken skin

Flammable: (FLAMMABLE:)

• do not use near heat, flame or while smoking



• avoid long term storage above 104°F (40°C)

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients (Inactive ingredients)

SD Alcohol 40-B, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Octylacrylamide Copolymer, Diisopropyl Sebacate, Lauryl Lactate, Fragrance (Natural Fragrance), Caprylic/Capric Triglyceride, Glycerin, Rubus Idaeus (Red Raspberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

Keep Out of Reach of Children. (Keep out of reach of children.)

​If product is swallowed, get medical help or contact a Poison Control Center right away.

​stop Use and Ask Doctor If​ (​Stop use and ask doctor if​)
  • rash occurs.

Advanced Ingredient Data


Raw Label Data

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