NEOVA DNA DAMAGE CONTROL - SILC SHEER SPF 45- octinoxate, titanium dioxide emulsion

Neova DNA Damage Control - Silc Sheer by

Drug Labeling and Warnings

Neova DNA Damage Control - Silc Sheer 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 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.jpg PkgInsertUniversalpg2.jpg AmpuleSHEER.jpg PouchSHEER.jpg

INGREDIENTS AND APPEARANCE

NEOVA DNA DAMAGE CONTROL - SILC SHEER   SPF 45
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62362-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6.5 mL  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	3.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62362-149-03	1 in 1 POUCH
1	NDC: 62362-149-02	2 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/09/2012

Labeler - PhotoMedex, Inc. (054503875)

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