Coola Bare Republic Clearscreen Spf50 Lotion

Coola Bare Republic Clearscreen Spf50 Lotion
SPL v4
SPL
SPL Set ID bcbab676-fbe2-f0cc-e053-2a95a90ad4d2
Route
TOPICAL
Published
Effective Date 2022-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (90 mg) Avobenzone (30 mg) Octocrylene (50 mg) Octisalate (40 mg)
Inactive Ingredients
Cetyl Palmitate Water Neopentyl Glycol Diheptanoate Cetyl Alcohol Raspberry Seed Oil Cetearyl Glucoside Cetearyl Olivate Benzyl Alcohol Chlorphenesin Vinylpyrrolidone/hexadecene Copolymer Silicon Dioxide Hyaluronate Sodium Carrot Seed Oil Glyceryl 1-stearate Xanthan Gum Sorbitan Olivate .alpha.-tocopherol, Dl- Grape Seed Oil Sodium Hydroxide Phytate Sodium Arachidyl Alcohol Glycerin Stearyl/octyldodecyl Citrate Crosspolymer Butyloctyl Salicylate Medium-chain Triglycerides Ethylhexylglycerin Sorbitan Monopalmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

Avobenzone 3.0% Homosalate 9.0% Octisalate 4.0% Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 9.0% Octisalate 4.0% Octocrylene 5.0%

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
  • apply liberally 15 minutes before sun exposure

  • reapply:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

  • children under 6 months of age: 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.
Other Information
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 4.0%

Octocrylene 5.0%

Inactive Ingredients

Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Gluoside, Cetearyl Olivate, Cetyl Palmitate, Chlorophenesin, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Hyaluronate, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Sorbitan Palmitate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl (Vitamin E), Vitis Vinifera (Grape) Seed Oil, VP/Hexadecene Copolymer, Water, Xanthan Gum

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
Keep Out of the Reach of Children

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


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
  • apply liberally 15 minutes before sun exposure

  • reapply:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

  • children under 6 months of age: 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.
Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 4.0%

Octocrylene 5.0%

Inactive Ingredients

Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Gluoside, Cetearyl Olivate, Cetyl Palmitate, Chlorophenesin, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Hyaluronate, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Sorbitan Palmitate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl (Vitamin E), Vitis Vinifera (Grape) Seed Oil, VP/Hexadecene Copolymer, Water, Xanthan Gum

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

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