NEOVA DNA DAMAGE CONTROL - SILC SHEER SPF 45- octinoxate, titanium dioxide 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 - Silc Sheer SPF 45 - Drug Facts

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.jpgBox DNADControlSHEERLabel.jpgLabel

NEOVA DNA DAMAGE CONTROL - SILC SHEER  SPF 45
octinoxate, titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-149
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.5 mL  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62362-149-011 in 1 BOX
1NDC:62362-149-7474 mL in 1 BOTTLE
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: cc4ff974-a89e-4731-a823-4be5d3869f24
Set id: 48392fd0-7695-4c2f-ae29-28fb692ab969
Version: 1
Effective Time: 20120106
 
PhotoMedex, Inc.