NEOVA DNA DAMAGE CONTROL - ACTIVE SPF 45- zinc oxide, octinoxate, octisalate emulsion

Neova DNA Damage Control - Active by

Drug Labeling and Warnings

Neova DNA Damage Control - Active by is a Otc medication manufactured, distributed, or labeled by PhotoMedex, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.jpg PouchActive.jpg PkgInsertUniversalpg1.jpg PkgInsertUniversalpg2.jpg

INGREDIENTS AND APPEARANCE

NEOVA DNA DAMAGE CONTROL - ACTIVE   SPF 45
zinc oxide, octinoxate, octisalate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62362-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	8 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62362-129-03	1 in 1 POUCH
1	NDC: 62362-129-02	2 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/06/2012

Labeler - PhotoMedex, Inc. (054503875)

Establishment
Name	Address	ID/FEI	Business Operations
PhotoMedex, Inc.		054503875	manufacture