Neova Day Therapy by PhotoMedex, Inc Neova Day Therapy

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]

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

Active Ingredients            Purpose

Avobenzone 3%                     Sunscreen

Homosalate 7%                      Sunscreen

Octisalate 5%                        Sunscreen

Octocrylene 6%                     Sunscreen

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Uses

• Helps prevent sunburn 
  
• if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun.
  

Warnings   

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions 

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months of age: ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including

•  Limit time in the sun, especially from 10 a.m.- 2 p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses.                                

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

Other Information   Protect this product from excessive heat and direct sun.

Questions or Comments? Call toll free 1-888-966-1010.

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 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COPPER PIDOLATE (UNII: 497G7G1SL1)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62362-184-04	1 in 1 CARTON	10/01/2010
1	NDC: 62362-184-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 62362-184-02	2 mL in 1 PACKET; Type 0: Not a Combination Product	10/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2010	06/30/2019

Labeler - PhotoMedex, Inc (054503875)

Revised: 6/2019

Document Id: 8ad2f0c9-e02d-4cc0-bc24-21dcd1328085

34390-5

Set id: 94f44409-4fc8-44ad-bf93-9e61dd505644

Version: 24

Effective Time: 20190619

 

PhotoMedex, Inc