NEOVA DNA DAMAGE CONTROL - ACTIVE SPF 45- zinc oxide, octinoxate, octisalate 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 - Active SPF 45 - Drug Facts

Active Ingredients

Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%

Purpose

Zinc Oxide - sunscreen, Octinoxate - sunscreen, Octisalate - 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 liberally before sun exposure.
• 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

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 Box and Label

BoxLabel

NEOVA DNA DAMAGE CONTROL - ACTIVE  SPF 45
zinc oxide, octinoxate, octisalate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide8 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62362-129-011 in 1 BOX
1NDC:62362-129-8989 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/05/2012
Labeler - PhotoMedex, Inc. (054503875)
Establishment
NameAddressID/FEIBusiness Operations
PhotoMedex, Inc.054503875manufacture

Revised: 1/2012
Document Id: c1d6e09b-2903-44ed-84a9-8701a702e19e
Set id: d2e404d0-2d91-485a-a1ac-d109f96603ce
Version: 6
Effective Time: 20120105
 
PhotoMedex, Inc.