NEOVA DNA DAMAGE CONTROL - ACTIVE SPF 45- zinc oxide, octinoxate, octisalate emulsion

Neova DNA Damage Control - Active by

Drug Labeling and Warnings

Neova DNA Damage Control - Active by is a Otc medication manufactured, distributed, or labeled by PhotoMedex, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NEOVA DNA DAMAGE CONTROL - ACTIVE  SPF 45
zinc oxide, octinoxate, octisalate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62362-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	8 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62362-129-01	1 in 1 BOX
1	NDC: 62362-129-89	89 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/05/2012

Labeler - PhotoMedex, Inc. (054503875)

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