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KINESYS

KINeSYS Pharmaceutical Inc.

SPF 50 Funscreen™ Spray-On Sunscreen for Kids


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DIRECTIONS

Apply generously prior to sun exposure. Reapply as needed or after swimming, towel drying, perspiring heavily or washing. To increase protection, re-apply at least every two hours. Do not spray directly onto the face. Spray into hands, and apply to the face.

WARNINGS

Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. For external use only.

Keep out of reach of children.

Consult a health care practitioner prior to use on children less than six months of age.

Do not use near flame or while smoking. This product is waterproof and may attract dirt and stains on some fabrics. Pre-spot prior to washing to remove sunscreen. Do not use chlorine bleach.

ACTIVE INGREDIENTS

Homosalate 15%, Oxybenzone 6%, Octisalate 5%, Avobenzone (Parsol® 1789) 3%.

INACTIVE INGREDIENTS

Dimethicone, Alcohol Denat., Phenyl Trimethicone, Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Dodecane, Tocopherol, Bisabolol.

Manufactured for KINeSYS Pharmaceutical Inc.
Richmond, B.C. V6V 2L9

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

SPF 50

fun
screen™
SPRAY–ON
Sunscreen
for KIDS

KINeSYS ®

Oil–Free

  • UVA/UVB protection UVA/UVB
  • Waterproof
  • Fragrance-free

120 mL (4 FL OZ)

Spray Emulsion

DIN 02336839

KINESYS

KINESYS

HOMOSALATE, OXYBENZONE, OCTISALATE, and AVOBENZONE SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61481-0680
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 15 g
OXYBENZONE OXYBENZONE 6 g
OCTISALATE OCTISALATE 5 g
AVOBENZONE AVOBENZONE 3 g

Inactive Ingredients

Ingredient Name Strength
DIMETHICONE
ALCOHOL
PHENYL TRIMETHICONE
BUTYLOCTYL SALICYLATE
DODECANE
Tocopherol
LEVOMENOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61481-0680-1 120 in 1 BOTTLE, SPRAY
2 NDC:61481-0680-2 30 in 1 BOTTLE, SPRAY
3 NDC:61481-0680-1 120 in 1 BOTTLE, SPRAY
4 NDC:61481-0680-3 2 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-06-20


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