Label: NEOVA DAY THERAPY SPF 30- homosalate, octocrylene, octisalate, avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 11, 2012

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  • 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

  • INGREDIENTS AND APPEARANCE
    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
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