KINESYS SPF 30 SOLID SUNSCREEN

Dosage form: stick
Ingredients: OCTINOXATE 7.5g in 100g, OCTISALATE 5g in 100g, OXYBENZONE 4.5g in 100g, TITANIUM DIOXIDE 1g in 100g
Labeler: KINeSYS Pharmaceutical Inc.
NDC Code: 61481-0045

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.

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0045
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE4.5 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PPG-2 MYRISTYL ETHER PROPIONATE 
STEARYL ALCOHOL 
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE 
CANDELILLA WAX 
C10-30 CHOLESTEROL/LANOSTEROL ESTERS 
TRIBEHENIN 
Packaging
#Item CodePackage Description
1NDC:61481-0045-17.3 g in 1 TUBE
2NDC:61481-0045-24 g in 1 TUBE
3NDC:61481-0045-31 TUBE in 1 PACKAGE
3NDC:61481-0045-17.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/20/2012
Labeler - KINeSYS Pharmaceutical Inc. (252292719)

Revised: 06/2012
 
KINeSYS Pharmaceutical Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)