Kinesys ®

Kinesys ®
SPL v8
SPL
SPL Set ID 998fe524-6469-4c9b-889b-3191882149ce
Route
TOPICAL
Published
Effective Date 2025-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Octinoxate (75 mg) Homosalate (50 mg) Octisalate (30 mg) Avobenzone
Inactive Ingredients
Cyclomethicone 5 Butyloctyl Salicylate Ethylhexyl Methoxycrylene Diphenylsiloxy Phenyl Trimethicone Vinylpyrrolidone/hexadecene Copolymer Octyldodecanol Tocopherol Levomenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-27

Description

Avobenzone 3.00% w/w Homosalate 7.50% w/w Octinoxate 7.50 % w/w Octisalate 5.00% w/w Octocrylene 10.00% w/w

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% w/w Homosalate 7.50% w/w Octinoxate 7.50 % w/w Octisalate 5.00% w/w Octocrylene 10.00% w/w

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
Warnings

For external use only

Directions
  • Hold container 4 to 6 inches from the skin to apply
  • Apply generously and spread evenly by hand 15 minutes before sun exposure
  • Reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Do not spray directly onto the face. Spray into hands, and apply to the face.
  • Do not apply in windy condition
  • Use in well-ventilated area
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Do Not Use
  • on damaged or broken skin
  • near flame or while smoking
Product Label

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3.00% w/w

Homosalate 7.50% w/w

Octinoxate 7.50 % w/w

Octisalate 5.00% w/w

Octocrylene 10.00% w/w

Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Octyldodecanol, Tocopherols, VP/Hexadecene Copolymer.

Questions Or Comments?

1-888-KINeSYS [546.3797] www.kinesysactive.com

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

Sunscreen

Warnings

For external use only

Directions
  • Hold container 4 to 6 inches from the skin to apply
  • Apply generously and spread evenly by hand 15 minutes before sun exposure
  • Reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Do not spray directly onto the face. Spray into hands, and apply to the face.
  • Do not apply in windy condition
  • Use in well-ventilated area
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Do Not Use (Do not use)
  • on damaged or broken skin
  • near flame or while smoking
Product Label (Product label)

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3.00% w/w

Homosalate 7.50% w/w

Octinoxate 7.50 % w/w

Octisalate 5.00% w/w

Octocrylene 10.00% w/w

Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Octyldodecanol, Tocopherols, VP/Hexadecene Copolymer.

Questions Or Comments? (Questions or Comments?)

1-888-KINeSYS [546.3797] www.kinesysactive.com

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor (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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