NEOVA DNA DAMAGE CONTROL - ACTIVE BROAD SPECTRUM SPF 43- octinoxate, zinc oxide cream

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 PHARMA COSMETICS, INC, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%, 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

Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyldimethicone Crosspolymer, Ergothioneine, Ethyl Hexyl Isononanoate,Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Lecithin, Microcoous Lysate, Phenoxyethanol, Plankton Extract, Purified Water, Retinyl Palmitate, Sodium Chloride, Sodium Hydroxide, Triethanoxycaprylylsilane.

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-888-966-1010.

Priduct Label

Neova DNA Damage Control
Active SPF 43
3.0 fl. oz. (89mL)

INGREDIENTS AND APPEARANCE

NEOVA DNA DAMAGE CONTROL - ACTIVE  BROAD SPECTRUM SPF 43
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72251-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72251-003-89	1 in 1 BOX	04/19/2018
1		89 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

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

Labeler - PHARMA COSMETICS, INC (080622701)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72251-003)