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Kinesys

KINeSYS Pharmaceuticals Inc.

Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free Spray Sunscreen


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

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

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

Inactive Ingredients

Cyclopentasiloxane, Octyl Palmitate, Butyloctyl Salicylate, Diphenylsioxy Phenyl Trimethicone, VP/ Hexadecene Copolymer, Tocopheryl Acetate, Bisabolol.

Other Information

  • protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

BROAD SPECTRUM
SPF
30
KiDS

Alcohol–Free
Spray Sunscreen

KINeSYS®

Oil–Free Preservative–Free

Fragrance-Free

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:61481-3002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 g
OCTOCRYLENE Octocrylene 7.5 g
OCTISALATE OCTISALATE 5 g
AVOBENZONE AVOBENZONE 2.5 g

Inactive Ingredients

Ingredient Name Strength
CYCLOMETHICONE 5
ETHYLHEXYL PALMITATE
BUTYLOCTYL SALICYLATE
DIPHENYLSILOXY PHENYL TRIMETHICONE
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)
.ALPHA.-TOCOPHEROL ACETATE, DL-
LEVOMENOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61481-3002-4 120 in 1 BOTTLE, SPRAY
2 NDC:61481-3002-1 30 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-03-01


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