KINESYS SPF 50 Funscreen Sunscreen for Kids

Dosage form: spray
Ingredients: HOMOSALATE 15g in 100mL, OXYBENZONE 6g in 100mL, OCTISALATE 5g in 100mL, AVOBENZONE 3g in 100mL
Labeler: KINeSYS Pharmaceutical Inc.
NDC Code: 61481-0680

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SPF 50 Funscreen™ Spray-On Sunscreen for Kids

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   SPF 50 FUNSCREEN SUNSCREEN FOR KIDS
homosalate, oxybenzone, octisalate, and avobenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0680
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE15 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE6 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
ALCOHOL 
PHENYL TRIMETHICONE 
BUTYLOCTYL SALICYLATE 
DODECANE 
TOCOPHEROL 
LEVOMENOL 
Packaging
#Item CodePackage Description
1NDC:61481-0680-1120 mL in 1 BOTTLE, SPRAY
2NDC:61481-0680-230 mL in 1 BOTTLE, SPRAY
3NDC:61481-0680-32 BOTTLE, SPRAY in 1 PACKAGE, COMBINATION
3NDC:61481-0680-1120 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/20/2012
Labeler - KINeSYS Pharmaceutical Inc. (252292719)

Revised: 06/2012
 
KINeSYS Pharmaceutical Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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