AVON NUTRA EFFECTS BALANCE DAY CREAM- octinoxate, homosalate, avonbenzone, oxybenzone cream

Avon Nutra Effects by

Drug Labeling and Warnings

Avon Nutra Effects by is a Otc medication manufactured, distributed, or labeled by Avon Products, Inc., Avon Manufacturing (Guangzhou) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Octinoxate 5.5%......

Homosalate 5.0%....

Avonbenzone 2.9%.....

Oxybenzone 1.0%......

PURPOSE

Purpose

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

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

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

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

INDICATIONS & USAGE

Uses

Helps prevent sunburn.

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product, keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other Information

• Protect the product in this container from excessive heat and direct sun,
• Product may stain fabrics.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVON NUTRA EFFECTS  BALANCE DAY CREAM
octinoxate, homosalate, avonbenzone, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71110-0015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	55 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71110-0015-1	1.1 g in 1 PACKET; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2016

Labeler - Avon Products, Inc. (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Manufacturing (Guangzhou) Ltd		544863277	manufacture(71110-0015)