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 - 50mL - 1.7 fl. oz.

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.

Active Ingredients

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

Inactive 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) Kernel Oil, Squalane,
Ammonium Acrylate/Acrylamide Copolymer, Polyisobutene, Polysorbate
20, Sodium Hydroxide, Lecithin, Sodium Chloride, Phenoxyethanol, Sorbic
Acid. May Contain +/- Ultramarines.

Image of Package Insert, box, and label

PkgInsertComboTherapypg1.jpgPackage Insert page 1 PkgInsertComboTherapypg2.jpgPackage Insert page 2 DayTherapy50mLImpt.jpgLabel DayTherapy50mLBox.jpgBox

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:62362-184-051 in 1 BOX
1NDC:62362-184-5050 mL in 1 BOTTLE, PUMP
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: adc0c9f7-391a-46d8-aff7-015f380eac70
Set id: a502bff0-74c6-46c2-92b1-f3dadf524e74
Version: 6
Effective Time: 20120111
 
PhotoMedex, Inc.