Fruit Of The Earth Sun Town City Spf 50 Lotion Sunscreen

Fruit Of The Earth Sun Town City Spf 50 Lotion Sunscreen
SPL v2
SPL
SPL Set ID c7a4783f-477f-1524-e053-2995a90a5ad9
Route
TOPICAL
Published
Effective Date 2019-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (45 mg) Octocrylene (80 mg)
Inactive Ingredients
Water Glycerin Polyester-7 Neopentyl Glycol Diheptanoate Aluminum Starch Octenylsuccinate Silicon Dioxide Phenoxyethanol Isododecane Arachidyl Alcohol Ethylhexylglycerin Carbomer Copolymer Type A Docosanol .alpha.-tocopherol, Dl- White Wax Arachidyl Glucoside Potassium Hydroxide Glyceryl 1-stearate Peg-100 Stearate Edetate Disodium Sodium Ascorbyl Phosphate Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-10

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

Uses

• helps prevent sunburn • if used as directed with other sun protectino measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4

Warnings

For external use only

Do Not Use

• on damaged or broken skin.

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.,.

• wear long-sleeved shirts, pants, hats, and sunglasses

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 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Inactive Ingredients

water, polyester-7, neopentyl glycol diheptanoate, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

• if rash occurs.

Keep Out of 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 protectino measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Do Not Use (Do not use)

• on damaged or broken skin.

directions (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.,.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information (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 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Inactive Ingredients (Inactive ingredients)

water, polyester-7, neopentyl glycol diheptanoate, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

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)

• if rash occurs.

Keep Out of Reach of Children. (Keep out of 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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