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

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.

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SPF 30 Sun Protection Stick

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

KINeSYS®

7.3g (0.26 OZ)
DIN 02237002

EarthKind

PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label
KINESYS  SPF 30 SOLID SUNSCREEN
octinoxate, octisalate, oxybenzone, and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61481-0045-17.3 g in 1 TUBE; Type 0: Not a Combination Product06/20/2012
2NDC:61481-0045-24 g in 1 TUBE; Type 0: Not a Combination Product06/20/2012
3NDC:61481-0045-31 in 1 PACKAGE06/20/2012
3NDC:61481-0045-17.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/20/2012
Labeler - Wilc Healthcare Inc (203499140)
Registrant - Wilc Healthcare Inc (203499140)
Establishment
NameAddressID/FEIBusiness Operations
Cosmaceutical Research Laboratory Inc256797309manufacture(61481-0045)

Revised: 9/2019
Document Id: 4816feb1-df45-4363-b815-afb59f1ae732
Set id: e7a6941a-2ee1-4128-afac-c9349bac1096
Version: 2
Effective Time: 20190919
 
Wilc Healthcare Inc