ANEW VITALE DAY- octinoxate, octisalate, oxybenzone, avobenzone cream 
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 Cream Broad Spectrum SPF 25

Active Ingredients
Octinoxate 7.0%.................................
Octisalate 4.5%....................................
Oxybenzone 4.0%...............................
Avobenzone 2.8%..................................

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, dimethicone, glycerin, PEG-8, butyloctyl salicylate, cetearyl alcohol, trisiloxane, dilauryl thiodipropionate, phytol, behenyl alcohol,
thiodipropionic acid, panthenol, mesyloxybenzyl methoxyethyl chlorobenzamide, pichia ferment lysate filtrate, saccharomyces ferment lysate filtrate, palmitoyl tetrapeptide-10, kaempferia galanga root extract, polysorbate 60, ceteareth-20, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dimethicone crosspolymer, isohexadecane, carbomer, sodium hydroxide, disodium EDTA, caprylyl glycol, 1,2-hexanediol, parfum/fragrance.

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

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ANEW VITALE  DAY
octinoxate, octisalate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0319-21 in 1 CARTON03/17/2014
1NDC:10096-0319-150 g in 1 JAR; Type 0: Not a Combination Product
2NDC:10096-0319-41 in 1 CARTON03/17/2014
2NDC:10096-0319-315 g in 1 JAR; Type 0: Not a Combination Product
3NDC:10096-0319-51.1 g in 1 PACKET; Type 0: Not a Combination Product03/17/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/17/2014
Labeler - New Avon LLC (080143520)

Revised: 1/2019
Document Id: 8695e3ec-61a6-f2e4-e053-2a91aa0a15b0
Set id: 9f8ef748-fc61-4f49-909f-93fed9c8a08a
Version: 5
Effective Time: 20190101
 
New Avon LLC