KINESYS SPF 30 SOLID SUNSCREEN- octinoxate, octisalate, oxybenzone, and titanium dioxide stick

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]

Directions

Apply liberally 20 minutes prior to exposure to sun and wind. Re-apply every two hours to maximize protection. Re-apply to lips after eating or drinking. Store product below 30°C.

Warning

For external use only.

Discontinue use if signs of irritation or rash appear. Avoid contact with eyes.

Keep out of reach of children.

Do not use on infants less than six months of age.

Active Ingredients

Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4.5%, Titanium Dioxide 1%.

Inactive Ingredients

PPG-2 Myristyl Ether Propionate, Stearyl Alcohol, Pentaerythrityl Tetracaprylate/Caprate, Candelilla Wax, Synthetic Beeswax, C10-30 Cholesterol/Lanosterol Esters, Tribehenin.

PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label

SPF 30
sun protection stick

solid sunscreen for
LIPS, FACE AND BODY

Protects age spots, freckles,
wrinkles and scars

• non-comedogenic
• hypoallergenic
• fragrance-free
• UVA/UVB protection

KINeSYS®

7.3g (0.26 OZ)
DIN 02237002

EarthKind™

INGREDIENTS AND APPEARANCE

KINESYS  SPF 30 SOLID SUNSCREEN
octinoxate, octisalate, oxybenzone, and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61481-0045
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 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X)
CANDELILLA WAX (UNII: WL0328HX19)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
TRIBEHENIN (UNII: 8OC9U7TQZ0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61481-0045-1	7.3 g in 1 TUBE; Type 0: Not a Combination Product	06/20/2012
2	NDC: 61481-0045-2	4 g in 1 TUBE; Type 0: Not a Combination Product	06/20/2012
3	NDC: 61481-0045-3	1 in 1 PACKAGE	06/20/2012
3	NDC: 61481-0045-1	7.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/20/2012

Labeler - Wilc Healthcare Inc (203499140)

Registrant - Wilc Healthcare Inc (203499140)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture(61481-0045)