ANEW VITALE DAY- homosalate, octinoxate, oxybenzone, avobenzone lotion 
New Avon LLC

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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Anew Vitale Day Lotion Broad Spectrum SPF 25

Active Ingredients
Homosalate 8.0%............................
Octinoxate 5.0%..............................
Oxybenzone 4.0%.........................
Avobenzone 2.85%...........................

Purpose
............... Sunscreen
............... Sunscreen
.............. Sunscreen

.............. Sunscreen

Uses

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

​For sunscreen use:

Other Information

Inactive ingredients:
water/eau, butylene glycol, dimethicone, PEG-8, trisiloxane, glycerin, ethylhexyl isononanoate, HDI/trimethylol hexyllactone crosspolymer,
cetyl alcohol, caprylyl glycol, behenyl alcohol, dilauryl thiodipropionate, thiodipropionic acid, carbomer, glyceryl stearate, parfum/fragrance,
sodium hydroxide, phenoxyethanol, trimethylsiloxysilicate, hydrogenated lecithin, acrylates/C10-30 alkyl acrylate crosspolymer, disodium
EDTA, polyglyceryl-3 diisostearate, choleth-24, hexylene glycol, ceteth-24, panthenol, silica, mesyloxybenzyl methoxyethyl chlorobenzamide,
pichia ferment lysate filtrate, saccharomyces ferment lysate filtrate, palmitoyl tetrapeptide-10.

Questions?
1-800-FOR-AVON or 1-800-265-AVON in Canada

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ANEW VITALE  DAY
homosalate, octinoxate, oxybenzone, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0322-21 in 1 CARTON12/19/2014
1NDC:10096-0322-150 mL in 1 JAR; Type 0: Not a Combination Product
2NDC:10096-0322-41 in 1 CARTON12/19/2014
2NDC:10096-0322-315 mL in 1 JAR; Type 0: Not a Combination Product
3NDC:10096-0322-51.1 mL in 1 PACKET; Type 0: Not a Combination Product12/19/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/19/2014
Labeler - New Avon LLC (080143520)

Revised: 1/2019
Document Id: 8695f02f-d982-51fc-e053-2991aa0a9eb7
Set id: 7ba1d4aa-e976-4fa8-bce9-56a1642d762a
Version: 4
Effective Time: 20190101
 
New Avon LLC