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

Neova Day Therapy by

Drug Labeling and Warnings

Neova Day Therapy by is a Otc medication manufactured, distributed, or labeled by PhotoMedex, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.jpg PkgInsertComboTherapypg2.jpg DayTherapy50mLImpt.jpg DayTherapy50mLBox.jpg

INGREDIENTS AND APPEARANCE

NEOVA DAY THERAPY  SPF 30
homosalate, octocrylene, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62362-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	7 mL  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	6 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mL  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62362-184-05	1 in 1 BOX
1	NDC: 62362-184-50	50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/11/2012

Labeler - PhotoMedex, Inc. (054503875)

Establishment
Name	Address	ID/FEI	Business Operations
PhotoMedex, Inc.		054503875	manufacture