topcare everyday ultra protection sun lotion spf 50

topcare everyday ultra protection sun lotion spf 50
SPL v2
SPL
SPL Set ID c5601d22-2353-7319-e053-2a95a90a16c0
Route
topical
Published
Effective Date 2018-11-02
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 polyester-7 neopentyl glycol diheptanoate glycerin aluminum starch octenylsuccinate silicon dioxide phenoxyethanol isododecane arachidyl alcohol white wax ethylhexylglycerin butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer docosanol .alpha.-tocopherol, dl- arachidyl glucoside glyceryl stearate/peg-100 stearate potassium hydroxide edetate disodium sodium ascorbyl phosphate carbomer copolymer type a (allyl pentaerythritol crosslinked)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-02-11

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 casued 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 the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Inactive Ingredients

water, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, aluminum starch octenylsuccinate, 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

Description

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

Label

TOPCARE EVERYDAY ULTRA PROTECTION SUN LOTION SPF 50

8.0 FL OZ (237mL)

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 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 casued 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 the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Inactive Ingredients (Inactive ingredients)

water, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, aluminum starch octenylsuccinate, 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

Label

TOPCARE EVERYDAY ULTRA PROTECTION SUN LOTION SPF 50

8.0 FL OZ (237mL)

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 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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