Coola Bare Republic Clearscreen Spf100 Lotion

Coola Bare Republic Clearscreen Spf100 Lotion
SPL v3
SPL
SPL Set ID f14cf2b8-b110-1210-e053-2995a90a0102
Route
TOPICAL
Published
Effective Date 2022-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (150 mg) Avobenzone (30 mg) Octocrylene (100 mg) Octisalate (50 mg)
Inactive Ingredients
Water Raspberry Seed Oil Chlorphenesin Hyaluronate Sodium Carrot Seed Oil .alpha.-tocopherol, Dl- Grape Seed Oil Arachidyl Alcohol Glycerin Butyloctyl Salicylate Ethylhexylglycerin Tridecyl Salicylate Docosanol Glyceryl Monobehenate Trideceth-6 Phytate Sodium Polyurethane-62 Lauryl Lactate Lecithin, Soybean Arachidyl Glucoside Silicon Dioxide Ammonium Acryloyldimethyltaurate/vp Copolymer Isodecyl Neopentanoate Diisopropyl Sebacate 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-21
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
  • 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 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Inactive Ingredients

Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Diisopropyl Sebacate, Lauryl Lactate, Glyceryl Behenatae,Vitis Vinifera (Grape) Seed Extract, Daucus Carota Sativa (Carrot) Extract, Rubus Idaeus (Raspberry) Seed Extract, Sodium Hyaluronate, Glycerin, Ethylhexylglycerin, Chlorphenesin, Polyurethane-62, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Lecithin, Sodium Phytate

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 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Inactive Ingredients

Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Diisopropyl Sebacate, Lauryl Lactate, Glyceryl Behenatae,Vitis Vinifera (Grape) Seed Extract, Daucus Carota Sativa (Carrot) Extract, Rubus Idaeus (Raspberry) Seed Extract, Sodium Hyaluronate, Glycerin, Ethylhexylglycerin, Chlorphenesin, Polyurethane-62, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Lecithin, Sodium Phytate

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:43.223875 · Updated: 2026-03-14T23:11:28.912883