NEOVA DNA DAMAGE CONTROL - ACTIVE  SPF 45- 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 - Active SPF 45 - 2mL sample package insert

Directions for use:

Apply liberally to exposed skin every two hours. Reapply as needed. For optimal results, use daily with Neova [DNA + Copper] products.

Supplied

in a 3.0 fl. oz. / 89 mL tube.

Active Ingredients:

Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%.

Inactive Ingredients:

Water (Aqua), Cyclopentasiloxane,
Ethyl Hexyl Isononanoate, Micrococcus Lysate, Plankton
Extract, L-ergothioneine, Dimethicone, Dimethicone/
PEG-10/15 Crosspolymer, Lauryl PEG-9 Polymethylsiloxyethyl
Dimethicone, Dimethicone/Vinyl Dimethicone
Crosspolymer, Retinyl Palmitate, Ascorbyl Palmitate
(Vitamin C), Sodium Chloride, Phenoxyethanol, Butylene
Glycol, Iodopropynyl Butylcarbamate, Citric Acid,
Sodium Hydroxide.

Image of package, pouch, and package insert

AmpuleActive.jpgPackage PouchActive.jpgPouch PkgInsertUniversalpg1.jpgPackage Insert page 1 PkgInsertUniversalpg2.jpgPackage Insert page 2

NEOVA DNA DAMAGE CONTROL - ACTIVE   SPF 45
zinc oxide, octinoxate, octisalate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide8 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)  
Micrococcus Luteus (UNII: LV6L29Z6AX)  
Ergothioneine (UNII: BDZ3DQM98W)  
Dimethicone (UNII: 92RU3N3Y1O)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Citric Acid (UNII: 2968PHW8QP)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62362-129-031 in 1 POUCH
1NDC:62362-129-022 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: 657c11fe-04b0-46aa-bbbd-6b740934f08c
Set id: 7e8d82cd-1215-4cfd-bfba-611d3e4ad776
Version: 3
Effective Time: 20120106
 
PhotoMedex, Inc.