coola bare republic clearscreen spf100 lotion

coola bare republic clearscreen spf100 lotion
SPL v3
SPL
SPL Set ID f1504311-4865-5499-e053-2995a90acdcd
Route
topical
Published
Effective Date 2022-08-26
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 tridecyl salicylate docosanol glyceryl monobehenate 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) sodium polyacrylate (2500000 mw) ethylhexyl stearate trideceth-6 glyceryl caprylate phenylethyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-10-21

Purpose

Sunscreen

Description

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


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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

Other Information
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Inactive Ingredients

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

Description

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

Label

Do Not Use
  • on damaged or broken skin.
Active Ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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

Warnings

For external use only

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
Purpose

Sunscreen

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

Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Inactive Ingredients

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

Label

Do Not Use (Do not use)
  • on damaged or broken skin.
Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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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