NEOVA DNA DAMAGE CONTROL - SILC SHEER  SPF 45 - octinoxate, titanium dioxide emulsion 
PhotoMedex, 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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Neova DNA Damage Control - Silc Sheer SPF 45 - 2mL sample package insert

Directions for use:

Apply evenly to face. Reapply
as needed. For optimal results, use daily with Neova
[DNA + Copper] products.

Supplied

in a 2.5 fl. oz. / 74 mL bottle.

Active Ingredients:

Titanium Dioxide 3.5%, Octinoxate 6.5%.

Inactive Ingredients:

Camellia Sinensis Leaf Extract,
Aloe Barbadensis Extract, Octyl Stearate, Cyclomethicone,
Isopropyl Palmitate, Helianthus Annuus (Sunflower)
Seed Oil, Lauryl PEG-9 Polydimethylsiloxyethyl
Dimethicone, Micrococcus Lysate, Plankton Extract,
Xanthophyll, Rosmarinus Officinalis (Rosemary) Leaf
Extract, Squalane, Lecithin, Silica, Hydrated Silica,
Microcrystalline Wax, Cetyl Dimethicone, Hydrogenated
Castor Oil, Sodium Chloride, Phenoxyethanol, Iodopropynyl
Butylcarbamate, Melanin, Caramel, Iron Oxides,
CI 77499, CI 77491, CI 77492.

Image of package insert, package, and pouch

PkgInsertUniversalpg1.jpgPackage Insert page 1 PkgInsertUniversalpg2.jpgPackage Insert page 2 AmpuleSHEER.jpgAmpule PouchSHEER.jpgPouch

NEOVA DNA DAMAGE CONTROL - SILC SHEER   SPF 45
octinoxate, titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-149
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.5 mL  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Octyl Stearate (UNII: 772Y4UFC8B)  
Cyclomethicone (UNII: NMQ347994Z)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Sunflower Oil (UNII: 3W1JG795YI)  
Lutein (UNII: X72A60C9MT)  
Rosemary (UNII: IJ67X351P9)  
Squalane (UNII: GW89575KF9)  
Egg Phospholipids (UNII: 1Z74184RGV)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Caramel (UNII: T9D99G2B1R)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62362-149-031 in 1 POUCH
1NDC:62362-149-022 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/09/2012
Labeler - PhotoMedex, Inc. (054503875)
Establishment
NameAddressID/FEIBusiness Operations
PhotoMedex, Inc.054503875manufacture

Revised: 1/2012
Document Id: 0542c9e9-5d1f-4485-9568-fe9f48b1d220
Set id: 33c6f533-db32-4514-b034-ddd4151dc473
Version: 1
Effective Time: 20120109
 
PhotoMedex, Inc.