NEOVA DAY THERAPY SPF 30- homosalate, octocrylene, octisalate, avobenzone lotion 
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 Day Therapy - SPF 30 - 2ML - 0.07 FL. OZ - package insert

WARNINGS:

For external use only. Avoid contact
with eyes. If contact occurs, rinse eyes thoroughly
with water. Discontinue use if irritation or rash appears.
Keep out of reach of children. In case of accidental
ingestion, seek professional assistance or contact
a Poison Control Center immediately.

Directions:

Apply liberally to face and neck in the morning.

Supplied

in a 1.7 oz / 50mL airless pump.

Active Ingredients:

Homosalate 7%, Octocrylene, 6%,
Octisalate 5%, Avobenzone 3%

Purpose:

Sunscreen

Ingredients:

Water (Aqua), Isododecane, Hydrogenated
Polydecene, Glycerin, Glyceryl Stearate, Arachidyl
Alcohol, Behenyl Alcohol, Bis (Tripeptide-1) Copper
Acetate, Plankton Extract, Triticum Vulgare (Wheat)
Gluten Extract, Glycine Soja (Soybean) Seed Extract,
Dimethicone, Arachidyl Glucoside, Caprylyl Glycol,
Xanthan Gum, Cetyl Alcohol, PEG-100 Stearate, Prunus
Armeniaca (Apricot) Kernal Oil, Squalane, Ammonium
Acrylate/Acrylamide Copolymer, Polyisobutene, Polysorbate
20, Sodium Hydroxide, Lecithin, Sodium
Chloride, Phenoxyethanol, Sorbic Acid. May Contain
+/- Ultramarines.

Image of Packet, Packet Holder, Package Insert

DayTherapyFoilPacket.jpgPacket PacketHolderDayTherapypg1.jpgPacket Holder page 1 PacketHolderDayTherapypg2.jpgPacket Holder page 2 PkgInsertComboTherapypg1.jpgPackage Insert page 1 PkgInsertComboTherapypg2.jpgPackage Insert page 2

NEOVA DAY THERAPY  SPF 30
homosalate, octocrylene, octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate7 mL  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene6 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mL  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isododecane (UNII: A8289P68Y2)  
Hydrogenated Polydecene (550 MW) (UNII: U333RI6EB7)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Docosanol (UNII: 9G1OE216XY)  
Prezatide Copper Acetate (UNII: A3LEI4P1NB)  
Soybean (UNII: L7HT8F1ZOD)  
Dimethicone (UNII: 92RU3N3Y1O)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Xanthan Gum (UNII: TTV12P4NEE)  
Cetyl Alcohol (UNII: 936JST6JCN)  
PEG-100 Stearate (UNII: YD01N1999R)  
Apricot Kernel Oil (UNII: 54JB35T06A)  
Squalane (UNII: GW89575KF9)  
Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sorbic Acid (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62362-184-031 in 1 POUCH
1NDC:62362-184-072 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/11/2012
Labeler - PhotoMedex, Inc. (054503875)
Establishment
NameAddressID/FEIBusiness Operations
PhotoMedex, Inc.054503875manufacture

Revised: 1/2012
Document Id: a752b6e4-63cd-4812-9e70-82829e1a72dd
Set id: 2d320c79-9d09-424e-9f60-789ca2a75373
Version: 4
Effective Time: 20120111
 
PhotoMedex, Inc.