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]

Active Ingredients

Octinoxate 6.5%, Titanium Dioxide 3.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn. Higher SPF gives
more sunburn protection. Retains SPF after 80 minutes
of activity in the water or perspiring.

Warnings

For external use only

When using this product:

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if:

Rash or irritation develops and lasts.

Keep out of reach of children:

If swallowed, contact a Poison Control Center immediately or get medical help right away.

Directions

Apply every morning to face, neck
and décolletage. Reapply as needed or after towel
drying, swimming or perspiring.
Children under 6 months of age: ask a doctor.

Other Information

High protection sun product. Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Serious side effects associated with use of this product may be reported to this number: 888-966-1010.

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 box and label

DNADControlSHEERBox.jpg DNADControlSHEERLabel.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: 62362-149-01	1 in 1 BOX
1	NDC: 62362-149-74	74 mL in 1 BOTTLE

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