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Kinesys

KINeSYS Pharmaceuticals Inc.

Kinesys Broad Spectrum SPF 30 Girl 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, Fragrance.

Other Information

  • protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

BROAD SPECTRUM
spf
30
girl

Alcohol-Free
Spray SUNSCREEN

KINeSYS®

Oil-Free // Preservative-Free

Vanilla-Green Tea Scent

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:61481-3004
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:61481-3004-4 120 in 1 BOTTLE, SPRAY
2 NDC:61481-3004-1 30 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-03-04


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