AVON NUTRA EFFECTS BALANCE DAY CREAM- octinoxate, homosalate, avonbenzone, oxybenzone 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 5.5%......

Homosalate 5.0%....

Avonbenzone 2.9%.....

Oxybenzone 1.0%......

Purpose

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

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

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

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

Uses

Helps prevent sunburn.

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

Directions

For suncreen use:

Apply liberally and evenly 15 minutes before sun exposure.
Children under 6 months of age: ask a doctor.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
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 value of 15 or higher and other sun-procteion measures, including:
Limite time in the sun, expecially from 10 a.m.-2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Inactive ingredients

WATER/EAU, BUTYLENE GLYCOL, DIMETHICONE, ETHYLHEXYL ISONONANOATE, PEG-8, SILICA, GLYCERIN, POLYSILICONE-11, CAPRYLYL GLYCOL, PARFUM/FRAGRANCE, GLYCERYL STEARATE, HYDROGENATED LECITHIN, PHENOXYETHANOL, BEHENYL ALCOHOL, CETYL ALCOHOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, DISODIUM EDTA, PANTHENOL, TALC, CHOLETH-24, ISOHEXADECANE, SODIUM HYDROXIDE, HEXYLENE GLYCOL, CETETH-24, POLYGLYCERYL-3 DIISOSTEARATE, PYRIDOXINE HCL, POLYSORBATE 60, LAURETH-12, TOCOPHERYL ACETATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, PHYTOL, ISOMALT, MALTODEXTRIN, POUZOLZIA PENTANDRA EXTRACT, SALVIA HISPANICA SEED EXTRACT, LECITHIN, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT.

image of PDPimage of DFB

AVON NUTRA EFFECTS  BALANCE DAY CREAM
octinoxate, homosalate, avonbenzone, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71110-0015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
TALC (UNII: 7SEV7J4R1U)  
CHOLETH-24 (UNII: 5UE7I54O43)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CETETH-24 (UNII: 0EV3Z43Y2I)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PANTHENOL (UNII: WV9CM0O67Z)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHYTOL (UNII: 5BC2RZ81NG)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
ISOMALT (UNII: S870P55O2W)  
LAURETH-12 (UNII: OAH19558U1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71110-0015-11.1 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) Ltd544863277manufacture(71110-0015)

Revised: 6/2018
Document Id: 6d9a1754-8d49-054f-e053-2991aa0a4653
Set id: 6d9a1754-8d48-054f-e053-2991aa0a4653
Version: 1
Effective Time: 20180601
 
Avon Products, Inc.