ANEW ULTIMATE 7S DAY- homosalate, octinoxate, oxybenzone, avobenzone cream

Anew by

Drug Labeling and Warnings

Anew by is a Otc medication manufactured, distributed, or labeled by Avon Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
HOMOSALATE 8%, OCTINOXATE 5%, OXYBENZONE 4%,
AVOBENZONE 2.85%...................................................................

                                          Purpose
....................................................Sunscreen

INDICATIONS & USAGE

Uses
helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions
apply liberally 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 protection measures including:
    limit time in the sun, especially 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

INACTIVE INGREDIENT

Inactive ingredients: WATER/EAU, DIMETHICONE, BUTYLENE GLYCOL, GLYCOLIC ACID, GLYCERIN, BEHENYL ALCOHOL, HYDROGENATED POLYISOBUTENE, TRISILOXANE, ETHYLHEXYL ISONONANOATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETEARYL ALCOHOL, ISOHEXADECANE, PHYTOL, THIODIPROPIONIC ACID, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ECLIPTA PROSTRATA EXTRACT, PALMITOYL LYSYL AMINOVALEROYL LYSINE, PALMITOYL TETRAPEPTIDE-10, PALMITOYL TETRAPEPTIDE-7, MELICOPE HAYESII LEAF EXTRACT, SACCHAROMYCES FERMENT LYSATE FILTRATE, THIAZOLYLALANINE, MESYLOXYBENZYL ISOBUTYLBENZENESULFONAMIDE, PEG-100 STEARATE, CETEARYL GLUCOSIDE, DIMETHICONOL, POLYSORBATE 60, PEG-150 DISTEARATE, XANTHAN GUM, ISOMALT, LECITHIN, STEARETH-20, AMMONIUM HYDROXIDE, PHENOXYETHANOL, DISODIUM EDTA, PARFUM/FRAGRANCE, CARAMEL, RED 4/CI 14700.

QUESTIONS

Questions? 1-800-FOR-AVON

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW   ULTIMATE 7S DAY
homosalate, octinoxate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0266
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g  in 50 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.425 g  in 50 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0266-2	1 in 1 CARTON
1	NDC: 10096-0266-1	50 g in 1 JAR
2	NDC: 10096-0266-4	1 in 1 CARTON
2	NDC: 10096-0266-3	15 g in 1 JAR
3	NDC: 10096-0266-5	1.1 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/20/2011

Labeler - Avon Products, Inc. (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc.		005149471	manufacture