NEOVA DNA DAMAGE CONTROL - EVERYDAY  BROAD SPECTRUM SPF 44- octinoxate, octisalate, zinc oxide emulsion 
PHARMA COSMETICS, 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.

----------

Neova DNA Damage Control - Everyday SPF 44 - Drug Facts

Active Ingredients

Octinoxate 6.5%, Octisalate 2.5% Zinc Oxide 8.5%

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 on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 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

Allantoin, Ascorbyl Palmitate, Butylene Glycol, Cetearyl Glucoside, Citric Acid, Cyclopentasiloxane, Dimethicone, Ergothioneine, Ethyl Hexyl Isononanoate, Glycereth-26, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iodopropynyl Butylcarbamate, Isopropyl Palmitate, Lecithin, Micrococcus Lysate, Octyl Sterate, Oleth-3 Phosphate, Panthenol, PEG-7 Trimethylolprpopane Coconut Ether, Phenoxyethanol, Plankton Extract, Polyether-1, Polyisobutene, Purified Water, Retinyl Palmitate, Sodium Hyaluronate, Sodium Hydroxide, Tocopherol Acetate, Triethoxycaprylysilane.

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-888-966-1010.

Product Label

Neova DNA Damage Control
Everyday SPF 44
2.5 fl. oz. (74mL) label and box

everyday

NEOVA DNA DAMAGE CONTROL - EVERYDAY   BROAD SPECTRUM SPF 44
octinoxate, octisalate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72251-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
GLYCERETH-26 (UNII: NNE56F2N14)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
DODOXYNOL-5 (UNII: CSH59YN3D0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72251-002-7474 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package04/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/08/2012
Labeler - PHARMA COSMETICS, INC (080622701)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72251-002)

Revised: 11/2022
 
PHARMA COSMETICS, INC