ANEW VITALE DAY- octinoxate, octisalate, oxybenzone, avobenzone cream 
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

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.

image of PDPimage of DFB

ANEW VITALE  DAY
octinoxate, octisalate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71110-0008
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
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GLYCERIN (UNII: PDC6A3C0OX)  
THIODIPROPIONIC ACID (UNII: 3BBK323ED8)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PANTHENOL (UNII: WV9CM0O67Z)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
DILAURYL THIODIPROPIONATE (UNII: V51YH1B080)  
PHYTOL (UNII: 5BC2RZ81NG)  
MESYLOXYBENZYL METHOXYETHYL CHLOROBENZAMIDE (UNII: 3HB4C300XB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71110-0008-11.1 g in 1 PACKET; Type 0: Not a Combination Product03/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2016
Labeler - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Manufacturing (Guangzhou) Ltd.544863277manufacture(71110-0008)

Revised: 6/2018
Document Id: 6d954916-a1b6-1388-e053-2a91aa0a0a95
Set id: 6d954916-a1b5-1388-e053-2a91aa0a0a95
Version: 1
Effective Time: 20180601
 
Avon Products, Inc.