kinesys®

kinesys®
SPL v2
SPL
SPL Set ID 3f42f0b8-dbd0-424e-bfe6-587391716101
Route
topical
Published
Effective Date 2017-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 g) octocrylene (5 g) octisalate (2.5 g) avobenzone
Inactive Ingredients
cyclomethicone 5 ethylhexyl palmitate butyloctyl salicylate diphenylsiloxy phenyl trimethicone vinylpyrrolidone/hexadecene copolymer tocopherol levomenol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-06-05

Purpose

Sunscreen

Description

Avobenzone 2.5% Octinoxate 7.5% Octisalate 5.0% Octocrylene 7.5%


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

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, Fragrance, Octyl Palmitate, Tocopherols, VP/ Hexadecene Copolymer.

Description

Avobenzone 2.5% Octinoxate 7.5% Octisalate 5.0% Octocrylene 7.5%

Do Not Use
  • on damaged or broken skin
Active Ingredients

Avobenzone 2.5%

Octinoxate 7.5%

Octisalate 5.0%

Octocrylene 7.5%



Questions Or Comments?

1-888-KINeSYS

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.

Principal Display Panel 30 Ml Bottle Label

NDC 61481-3004-1

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

  • Clear Spray
  • Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

1.0 FL OZ (30 mL)

NDC 61481-3004-4

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

Clear Spray

Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

4.0 FL OZ (120 mL)


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

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, Fragrance, Octyl Palmitate, Tocopherols, VP/ Hexadecene Copolymer.

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

Avobenzone 2.5%

Octinoxate 7.5%

Octisalate 5.0%

Octocrylene 7.5%



Questions Or Comments? (Questions or Comments?)

1-888-KINeSYS

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.

Principal Display Panel 30 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label)

NDC 61481-3004-1

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

  • Clear Spray
  • Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

1.0 FL OZ (30 mL)

NDC 61481-3004-4

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

Clear Spray

Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

4.0 FL OZ (120 mL)


Advanced Ingredient Data


Raw Label Data

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