ANEW VITALE DAY- homosalate, octinoxate, oxybenzone, avobenzone lotion 
Avon Products, 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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Active Ingredients

Homosalate 8%............................

Octinoxate 5%..............................

Oxybenzone 4%.........................

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.

image of PDPimage of DFB

ANEW VITALE  DAY
homosalate, octinoxate, oxybenzone, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71110-0017
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
PANTHENOL (UNII: WV9CM0O67Z)  
MESYLOXYBENZYL METHOXYETHYL CHLOROBENZAMIDE (UNII: 3HB4C300XB)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DILAURYL THIODIPROPIONATE (UNII: V51YH1B080)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
THIODIPROPIONIC ACID (UNII: 3BBK323ED8)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CHOLETH-24 (UNII: 5UE7I54O43)  
CETETH-24 (UNII: 0EV3Z43Y2I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71110-0017-11.1 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 - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Manufacturing (Guangzhou) Ltd544863277manufacture(71110-0017)

Revised: 12/2018
Document Id: 7cd83fde-3bcc-21a8-e053-2a91aa0a0057
Set id: 7cd832c4-bf60-1110-e053-2a91aa0a41ad
Version: 1
Effective Time: 20181212
 
Avon Products, Inc.