ANEW REVERSALIST DAY RENEWAL- octinoxate, octisalate, oxybenzone, avobenzone cream

Anew Reversalist by

Drug Labeling and Warnings

Anew Reversalist 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
OCTINOXATE 7.11%, OCTISALATE 4.75%,
OXYBENZONE 4.00%, 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 skin 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, GLYCERIN, BUTYLENE GLYCOL,
ISODECYL ISONONANOATE, TROMETHAMINE, DILAURYL THIODIPROPIONATE, PHYTOL,
THIODIPROPIONIC ACID, THIAZOLYLALANINE, SESBANIA GRANDIFLORA FLOWER EXTRACT,
AMORPHOPHALLUS CAMPANULATUS RHIZOME/ROOT EXTRACT, PUNICA GRANATUM FRUIT
JUICE, PALMITOYL LYSYL AMINOVALEROYL LYSINE, TOCOPHEROL, POLYSORBATE 20,
CETEARYL ALCOHOL, KAEMPFERIA GALANGA ROOT EXTRACT, ISOHEXADECANE,
CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, NYLON-12,
POLYMETHYLSILSESQUIOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL
TAURATE COPOLYMER, XANTHAN GUM, CETEARETH-20, HYDROGENATED LECITHIN, SILICA,
POLYSORBATE 60, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, DIMETHICONE
CROSSPOLYMER, POLYMETHYL METHACRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA,
PHENOXYETHANOL, PARFUM/FRAGRANCE.

QUESTIONS

Questions? Call 1-800-FOR-AVON

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW REVERSALIST  DAY RENEWAL
octinoxate, octisalate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	71.1 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40.0 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0181-2	1 in 1 CARTON
1	NDC: 10096-0181-1	50 g in 1 JAR
2	NDC: 10096-0181-4	1 in 1 CARTON
2	NDC: 10096-0181-3	15 g in 1 JAR
3	NDC: 10096-0181-6	1 in 1 CARTON
3	NDC: 10096-0181-5	7 g in 1 JAR
4	NDC: 10096-0181-7	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	12/15/2009

Labeler - Avon Products, Inc (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc		005149471	manufacture(10096-0181)