KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT- octinoxate, octocrylene, octisalate, and avobenzone spray

Kinesys by

Drug Labeling and Warnings

Kinesys by is a Otc medication manufactured, distributed, or labeled by Wilc Healthcare Inc, Cosmaceutical Research Laboratory Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Purpose

Sunscreen

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?

1-888-KINeSYS [546.3797]
www.kinesysactive.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

• Hold container 4 to 6 inches from skin to apply.
• Spray generously and spread evenly by hand 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.
• Do not apply in windy conditions.
• Use in well-ventilated area
• 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
  • children under 6 months: Ask a doctor

Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, Fragrance, Octyl Palmitate, Tocopherols, VP/ Hexadecene Copolymer.

Other Information

• protect this product from extreme temperatures. May stain or damage some fabrics and surfaces.

PRINCIPAL DISPLAY PANEL

120ML BOTTLE LABEL

BROAD SPECTRUM SPF 30 UVA + UVB

OIL FREE

CLEAR SPRAY

FOR ACTIVE SKIN

KINeSYS

Performance SUNSCREEN

BROAD SPECTRUM SPF30

MANGO

80 MINS WATER & SWEAT RESISTANT

4FL OZ(120ml)

NDC: 61481-3003-4

INGREDIENTS AND APPEARANCE

KINESYS  BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT
octinoxate, octocrylene, octisalate, and avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61481-3003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61481-3003-4	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2017
2	NDC: 61481-3003-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2017

Labeler - Wilc Healthcare Inc (203499140)

Registrant - Wilc Healthcare Inc (203499140)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture(61481-3003)