KINESYS SPF 30 SOLID SUNSCREEN: Package Insert and Label Information

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.

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 ™

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g OXYBENZONE (OXYBENZONE) OXYBENZONE 4.5 g in 100 g TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1 g in 100 g

Inactive Ingredients Ingredient Name Strength PPG-2 MYRISTYL ETHER PROPIONATE STEARYL ALCOHOL PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE CANDELILLA WAX C10-30 CHOLESTEROL/LANOSTEROL ESTERS TRIBEHENIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61481-0045-1 7.3 g in 1 TUBE None 2 NDC:61481-0045-2 4 g in 1 TUBE None 3 NDC:61481-0045-3 1 TUBE in 1 PACKAGE contains a TUBE (61481-0045-1) 3 NDC:61481-0045-1 7.3 g in 1 TUBE This package is contained within the PACKAGE (61481-0045-3)

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	Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture (61481-0045)

Revised: 09/2019 Wilc Healthcare Inc