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Kinesys

KINeSYS Pharmaceutical Inc.

Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen Fragrance-Free


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate 7.5%

Octocrylene 7.0%

Octisalate 4.0%

Avobenzone 2.0%

Purpose

Sunscreen

Kinesys 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

Questions or Comments?

1-877-KINeSYS
www.kinesys.com

Warnings

For external use only

Do not use on damaged or broken skin

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.

Do not use near flame or while smoking

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 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
  • Do not spray directly onto the face. Spray into hands, and apply to the face.
  • children under 6 months: Ask a doctor

Inactive Ingredients

Cyclopentasiloxane, Octyl Palmitate, PVP/Hexadecene Copolymer, Phenyl Trimethicone, Tocopheryl Acetate, Bisabolol, PEG/PPG-18/18 Dimethicone.

Other Information

  • protect this product from excessive heat and direct sun

Manufactured for
KINeSYS
Pharmaceutical Inc.
Richmond, BC
V6V 2L9

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

BROAD SPECTRUM
SPF 30

Alcohol-Free
Performance
Sunscreen

KINeSYS ®

Oil-Free // Preservative-Free
Fragrance-Free

earthkind
Ethical
Manufacturing

VERY WATER RESISTANT
(80 MINUTES)
1.0 FL OZ
(30 mL)

Kinesys

Kinesys

OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61481-0670
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 g
OCTOCRYLENE Octocrylene 7 g
OCTISALATE OCTISALATE 4 g
AVOBENZONE AVOBENZONE 2 g

Inactive Ingredients

Ingredient Name Strength
CYCLOMETHICONE 5
ETHYLHEXYL PALMITATE
PHENYL TRIMETHICONE
.ALPHA.-TOCOPHEROL ACETATE
LEVOMENOL
PEG/PPG-18/18 DIMETHICONE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61481-0670-1 120 in 1 BOTTLE, SPRAY
2 NDC:61481-0670-2 30 in 1 BOTTLE, SPRAY
3 120 in 1 BOTTLE, SPRAY
4 NDC:61481-0670-3 1 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-05-15


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