KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN- 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 Girl Alcohol-Free Spray Sunscreen

Active Ingredients

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

Purpose

Sunscreen

Uses

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

Inactive Ingredients

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

Other Information

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

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

1.0 FL OZ (30 mL)

Label

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)

Label 1

KINESYS  BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN
octinoxate, octocrylene, octisalate, and avobenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-3004
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:61481-3004-4120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/05/2017
2NDC:61481-3004-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/05/2017
Labeler - Wilc Healthcare Inc (203499140)
Registrant - Wilc Healthcare Inc (203499140)
Establishment
NameAddressID/FEIBusiness Operations
Cosmaceutical Research Laboratory Inc256797309manufacture(61481-3004)

Revised: 7/2017
Document Id: 357d069b-73d6-4559-9cc8-153ad123ab16
Set id: 3f42f0b8-dbd0-424e-bfe6-587391716101
Version: 2
Effective Time: 20170712
 
Wilc Healthcare Inc