KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN- 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

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

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
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 the skin to apply
• apply 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 condition
• 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 excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC: 61481-3004-1

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

• Clear Spray
• Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

1.0 FL OZ (30 mL)

NDC: 61481-3004-4

BROAD SPECTRUM SPF 30

Girl

Alcohol-Free Performance SUNSCREEN

KINeSYS®

Vanilla-Green Tea // Oil-Free

Clear Spray
Preservative-Free

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

4.0 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61481-3004
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: 61481-3004-4	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/05/2017
2	NDC: 61481-3004-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/05/2017

Labeler - Wilc Healthcare Inc (203499140)

Registrant - Wilc Healthcare Inc (203499140)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture(61481-3004)