NEOVA DNA DAMAGE CONTROL - EVERYDAY SPF 43- zinc oxide, octinoxate, octisalate 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 - Everyday SPF 43 - 2mL sample package insert

Directions for use:

Apply every morning to face, neck, décolletage
and hands. Reapply as needed. For optimal results, use daily
with Neova [DNA + Copper] products.

Supplied

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

Active Ingredients:

Zinc Oxide 7.5%, Octinoxate 7.5%, Octisalate 2.5%.

Inactive Ingredients:

Water (Aqua), Isopropyl Palmitate,
Octyl Stearate, Ethyl Hexyl Isononanoate, Cyclopentasiloxane,
Cetearyl Glucoside, Micrococcus Lysate,
Plankton Extract, L-ergothioneine, Dimethicone,
Glycereth-26, Sodium Hyaluronate, Panthenol, Allantoin,
Tocopheryl Acetate, Ascorbyl Palmitate (Vitamin C),
Oleth-3 Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl
Taurate Copolymer, Polyisobutene, PEG-7
Trimethylolpropane Coconut Ether, Lecithin, Polyether-1,
Phenoxyethanol, Butylene Glycol, Citric Acid, Iodopropynyl
Butylcarbamate, Triethoxycaprylylsilane.

Image of package insert, package, and pouch

PkgInsertUniversalpg1.jpgPackage Insert page 1 PkgInsertUniversalpg2.jpgPackage Insert page 2 AmpuleEday.jpgAmpule PouchEday.jpgPouch

NEOVA DNA DAMAGE CONTROL - EVERYDAY  SPF 43
zinc oxide, octinoxate, octisalate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.5 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Octyl Stearate (UNII: 772Y4UFC8B)  
Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Ergothioneine (UNII: BDZ3DQM98W)  
Dimethicone (UNII: 92RU3N3Y1O)  
Glycereth-26 (UNII: NNE56F2N14)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Panthenol (UNII: WV9CM0O67Z)  
Allantoin (UNII: 344S277G0Z)  
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
Egg Phospholipids (UNII: 1Z74184RGV)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Citric Acid (UNII: 2968PHW8QP)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62362-139-031 in 1 POUCH
1NDC:62362-139-022 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/06/2012
Labeler - PhotoMedex, Inc. (054503875)
Establishment
NameAddressID/FEIBusiness Operations
PhotoMedex, Inc.054503875manufacture

Revised: 1/2012
Document Id: a4c08463-942b-4f1d-a483-1d56aee78d85
Set id: 77a587f5-d532-405b-91d9-2f0b27c24617
Version: 1
Effective Time: 20120106
 
PhotoMedex, Inc.