coola classic sunscreen lotion fragrance-free

coola classic sunscreen lotion fragrance-free
SPL v4
SPL
SPL Set ID cfc21b1a-4a26-1573-e053-2995a90a2d50
Route
topical
Published
Effective Date 2018-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (100 mg) avobenzone (30 mg) octocrylene (80 mg) octisalate (45 mg)
Inactive Ingredients
water cetyl alcohol raspberry seed oil glyceryl 1-stearate .alpha.-tocopherol, dl- glycerin butyloctyl salicylate medium-chain triglycerides ethylhexylglycerin phenoxyethanol lycium barbarum fruit monarda didyma leaf .gamma.-nonalactone .gamma.-decalactone sodium ascorbyl phosphate allyl heptanoate 4-(p-hydroxyphenyl)-2-butanone stearic acid palmitic acid lauryl alcohol edetate disodium piperonal myristyl alcohol propylene glycol carboxymethylcellulose sodium (0.7 carboxymethyl substitution per saccharide; 1200 mpa.s at 1%) lecithin, soybean docosanol vanillin triethyl citrate cellulose, microcrystalline butylene glycol linseed oil .gamma.-octalactone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-01-01
Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 4.5% Octocrylene 8.0%

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

Alkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 4.5% Octocrylene 8.0%

Label

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

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 4.5%

Octocrylene 8.0%

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

Alkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)

Label

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

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 4.5%

Octocrylene 8.0%

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.490894 · Updated: 2026-03-14T23:11:22.461750