Topcare Everyday Sport Sun Lotion Broad Spectrum Spf 30

Topcare Everyday Sport Sun Lotion Broad Spectrum Spf 30
SPL v2
SPL
SPL Set ID f12c09b1-8ffe-4933-e053-2995a90a434f
Route
TOPICAL
Published
Effective Date 2019-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (80 mg) Octisalate (45 mg) Octocrylene (60 mg)
Inactive Ingredients
Water Glycerin Polyester-7 Neopentyl Glycol Diheptanoate Aluminum Starch Octenylsuccinate Silicon Dioxide Phenoxyethanol Isododecane Arachidyl Alcohol Ethylhexylglycerin Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) 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 2019-07-24

Description

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 4.5%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 4.5%, Octocrylene 6.0%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection mesaures (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

  • 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, espcially from 10 a.m.-2 p.m.

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

  • children under 6 months: Ask a doctor
do Not Use

• on damaged or broken skin

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 8.0%, Octisalate 4.5%, Octocrylene 6.0%

Inactive Ingredients

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

• rash occurs

keep Out of Reach of Children.

If product is 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 mesaures (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

  • 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, espcially from 10 a.m.-2 p.m.

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

  • children under 6 months: Ask a doctor
do Not Use (Do not use)

• on damaged or broken skin

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 (Active ingredients)

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 4.5%, Octocrylene 6.0%

Inactive Ingredients (Inactive ingredients)

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

• rash occurs

keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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