NEOVA DNA DAMAGE CONTROL - SILC SHEER BROAD SPECTRUM SPF 40- octinoxate, titanium dioxide, zinc oxide 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 3.0%, Titanium Dioxide 3.0%, Zinc Oxide 9.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed and with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun.

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply:

°After 80 minutes of swimming or sweating.
°Immediately after towel drying.
°At least every two hours.

• Children under 6 months of age: ask a doctor.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

°Limit time in the sun, especially from 10 a.m. - 2 p.m.

°Wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

Alumina, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Ergothioneine, HDI/Trimethylol Hexyllactone Crosspolymer, Iodopropynl Butylcarbamate, Iron Oxides, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Lecithin, Methicone, Micrococcus Lysate, Plankton Extract, Purified Water, Silica, Sodium Chloride, Sodium Hydroxide, Triethoxycaprylylsilane.

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-888-966-1010.

Neova DNA Damage ControlSilc Sheer SPF 402.5 fl. oz. (74 mL) label and box

DNADamageControl2-5ozSilcSheerLabel.jpg DNADamageControl2-5ozSilcSheerBox.jpg

INGREDIENTS AND APPEARANCE

NEOVA DNA DAMAGE CONTROL - SILC SHEER  BROAD SPECTRUM SPF 40
octinoxate, titanium dioxide, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62362-169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62362-169-01	1 in 1 BOX
1	NDC: 62362-169-74	74 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/08/2012

Labeler - PhotoMedex, Inc. (054503875)

Establishment
Name	Address	ID/FEI	Business Operations
PhotoMedex, Inc.		054503875	manufacture(62362-169)