kinesys ®

kinesys ®
SPL v6
SPL
SPL Set ID 9adea1a4-efa6-4fe1-85e8-ed69fa098a87
Route
topical
Published
Effective Date 2019-09-24
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 drug active Since 2017-06-01

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 away from the skin to apply.
  • spray 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 conditions
  • 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  extreme temperatures. May stain or damage some fabrics and surfaces.
Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, 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 [546.3797]

www.kinesysactive.com

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel 

120ML BOTTLE LABEL

BROAD SPECTRUM SPF 30 UVA + UVB

OIL FREE

CLEAR SPRAY

FOR ACTIVE SKIN

KINeSYS

Performance SUNSCREEN

BROAD SPECTRUM SPF30

KIDS

80 MINS WATER & SWEAT RESISTANT

4FL OZ(120ml)

NDC 61481-3002-4

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

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 away from the skin to apply.
  • spray 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 conditions
  • 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  extreme temperatures. May stain or damage some fabrics and surfaces.
Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, 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 [546.3797]

www.kinesysactive.com

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel  (PRINCIPAL DISPLAY PANEL )

120ML BOTTLE LABEL

BROAD SPECTRUM SPF 30 UVA + UVB

OIL FREE

CLEAR SPRAY

FOR ACTIVE SKIN

KINeSYS

Performance SUNSCREEN

BROAD SPECTRUM SPF30

KIDS

80 MINS WATER & SWEAT RESISTANT

4FL OZ(120ml)

NDC 61481-3002-4

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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