ANEW AGE-TRANSFORMING CONCEALER- titanium dioxide, octinoxate cream

Anew Age-Transforming by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Titanium Dioxide 6.62%.........................
Octinoxate 2.50%.................................

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

INDICATIONS & USAGE

Uses

• helps prevent sunburn

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, Butylene Glycol, Propylene Glycol Dicaprylate/Dicaprate, Cyclopentasiloxane, Glycolic Acid, Polysorbate 60, Glycol Stearate, PPG-2 Myristyl Ether Propionate, Silica, Sorbitan Stearate, Foeniculum Vulgare (Fennel) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Vitis Vinifera (Grape) Fruit Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Olea Europaea (Olive) Leaf Extract, Medicago Sativa (Alfalfa) Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Punica Granatum Extract,
Hydrolyzed Hibiscus Esculentus Extract, Portulaca Oleracea Extract, Saxifraga Sarmentosa Extract, Tilia Cordata Wood Extract, Panax Ginseng Root Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Yeast Extract/Extrait De Levure, Padina Pavonica Thallus Extract, Hydrolyzed Wheat Protein, Talc, Nylon-12, PEG-12 Dimethicone, Ammonium Hydroxide, Magnesium Aluminum Silicate, Paraffin, Xanthan Gum, Xymenynic Acid, Mannitol, Polymethyl Methacrylate, Phytol, Alumina, Glycogen, PEG-40 Hydrogenated Castor Oil, Calcium Pantothenate, Biotin, Tetrasodium EDTA, Imidazolidinyl Urea, Propylparaben, Methylparaben, Aluminum Hydroxide. May Contain: Iron Oxides, Mica, Bismuth Oxychloride, Titanium Dioxide.

QUESTIONS

Questions or Comments?
Call toll free 1-800-FOR-AVON or 1-800-265-AVON in Canada

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW AGE-TRANSFORMING  CONCEALER
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	66.2 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	25 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0138-2	1 in 1 CARTON
1	NDC: 10096-0138-1	1.7 g in 1 VIAL, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/09/2013

Labeler - New Avon LLC (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc		005149471	manufacture(10096-0138)