KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT- octinoxate, octocrylene, octisalate, and avobenzone spray 
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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Kinesys® Broad Spectrum SPF 30 Alcohol-Free Spray Sunscreen - Mango Scent

Active Ingredients

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

Purpose

Sunscreen

Uses

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

Inactive Ingredients

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

Other Information

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

Label

KINESYS  BROAD SPECTRUM SPF 30 ALCOHOL-FREE SUNSCREEN - MANGO SCENT
octinoxate, octocrylene, octisalate, and avobenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-3003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61481-3003-4120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2017
2NDC:61481-3003-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2017
Labeler - Wilc Healthcare Inc (203499140)
Registrant - Wilc Healthcare Inc (203499140)
Establishment
NameAddressID/FEIBusiness Operations
Cosmaceutical Research Laboratory Inc256797309manufacture(61481-3003)

Revised: 10/2019
Document Id: 73aacd8d-689f-4ec8-bcfb-6caebdb37a13
Set id: 60e7ed8e-f421-4e08-97a8-af647200e4ae
Version: 5
Effective Time: 20191023
 
Wilc Healthcare Inc