Procyte Z-Silc Plus SPF 30

Dosage form: emulsion
Ingredients: ZINC OXIDE 9.0mL in 100mL, TITANIUM DIOXIDE 4.0mL in 100mL, ENSULIZOLE 2.0mL in 100 mL, OCTINOXATE 2.0mL in 100mL
Labeler: Northwest Cosmetic Laboratories
NDC Code: 62282-075

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.

Drug Facts

Active Ingredients:                     Purpose

Zinc Oxide 9.0%                                Sunscreen
Titanium Dioxide 4.0%                       Sunscreen
Ensulizole 2.0%                                 Sunscreen
Octinoxate 2.0%                                Sunscreen


Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • For skin highly sensitive to sunburn

Warnings   For external use only

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When using this product keep out of eyes. Rinse with water to remove.

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Stop use and ask a doctor if rash or irritation develops and lasts.

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Keep out of reach of children. If swallowed, contact Poison Control Center immediately or get medical help right away.


Directions

  • Apply liberally before sun exposure
  • Reapply as needed or after towel drying, swimming or perspiring.
  • Children under 6 months of age: ask a doctor

Other Information High protection sun product

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects associated with use of this product may be reported to this number: 888-966-1010.

Inactive Ingredients: Water, Isononyl Isononanoate, Cyclomethicone, Alumina, silica, Sodium Polyacrylate, Polyglyceryl-4 Isostearate, Cetyl Dimethicone Copolyol, Hexyl Laurate, Butylene Glycol, Phenoxyethanol, Chlorphensin, Glycerin, Methylparaben, Benzoic Acid, Hydrogenated Castor Oil, Ceresin, Tocopheryl Acetate, Cetyl Dimethicone, Magnesium Sulfate, Triethoxycaprylylsilane, Potassium Hydroxide, Caramel.




SUNBLOCK SPF

30+

Z-SILC
PLUS

UVA/UVB BROAD SPECTRUM
FOR NORMAL AND COMBINATION SKIN

PROCYTE

A PHOTOMEDEX COMPANY



NET CONTENTS 3.5 FL OZ (104 mL)


PROCYTE Z-SILC PLUS  SPF 30
zinc oxide, titanium dioxide, ensulizole, octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62282-075
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE9.0 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4.0 mL  in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE2.0 mL  in 100  mL
OCTINOXATE (OCTINOXATE) OCTINOXATE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
WATER 
CYCLOMETHICONE 
HEXYL LAURATE 
BUTYLENE GLYCOL 
CHLORPHENESIN 
GLYCERIN 
METHYLPARABEN 
BENZOIC ACID 
MAGNESIUM SULFATE, UNSPECIFIED 
POTASSIUM HYDROXIDE 
HYDROGENATED CASTOR OIL 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:62282-075-01104 mL in 1 TUBE
2NDC:62282-075-027 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2005
Labeler - Northwest Cosmetic Laboratories (929572014)

Revised: 12/2010
 
Northwest Cosmetic Laboratories

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.

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