ANEW REJUVENATE DAY REVITALIZING- octinoxate, octisalate, oxybenzone, avobenzone cream

Anew Rejuvenate by

Drug Labeling and Warnings

Anew Rejuvenate 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 7.5%, OCTISALATE 5.0%,
OXYBENZONE 4.75%, AVOBENZONE 3.0%...............................................................

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, ISODECYL ISONONANOATE, GLYCERIN, BUTYLENE GLYCOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DILAURYL THIODIPROPIONATE, POLYMETHYL METHACRYLATE, THIODIPROPIONIC ACID, SALICYLIC ACID, ECLIPTA PROSTRATA EXTRACT, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, PALMITOYL TETRAPEPTIDE-7, SODIUM HYALURONATE, PHYLLANTHUS EMBLICA FRUIT EXTRACT, FOENICULUM VULGARE (FENNEL) SEED EXTRACT, YEAST EXTRACT, SACCHAROMYCES LYSATE EXTRACT, KAEMPFERIA GALANGA ROOT EXTRACT, SACCHAROMYCES FERMENT FILTRATE, DIMETHICONE CROSSPOLYMER, SILICA, STEARETH-20, LACTOFERRIN, PHOSPHOLIPIDS, ISOHEXADECANE, HYDROGENATED LECITHIN, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, TROMETHAMINE, POLYSORBATE 60, METHYLPARABEN, DISODIUM EDTA, PROPYLPARABEN, PARFUM/FRAGRANCE, MICA/CI 77019, TITANIUM DIOXIDE/CI 77891.

QUESTIONS

Questions? 1-800-FOR-AVON

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW REJUVENATE  DAY REVITALIZING
octinoxate, octisalate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	47.5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0305-2	1 in 1 CARTON
1	NDC: 10096-0305-1	50 g in 1 JAR
2	NDC: 10096-0305-4	1 in 1 CARTON
2	NDC: 10096-0305-3	15 g in 1 JAR
3	NDC: 10096-0305-6	1 in 1 CARTON
3	NDC: 10096-0305-5	7 g in 1 JAR
4	NDC: 10096-0305-7	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	02/09/2013

Labeler - Avon Products, Inc (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc		005149471	manufacture(10096-0305)