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.

  • 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

  • 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:62362-184-031 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
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