ANEW AGE-TRANSFORMING FOUNDATION- octinoxate, titanium dioxide lotion

Anew Age-Transforming by

Drug Labeling and Warnings

Anew Age-Transforming 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 7.50%.........................................................................
Titanium Dioxide 4.00%.................................................................

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, Cyclopentasiloxane, Glycerin, Propylene Glycol Isoceteth-3 Acetate, Glycolic Acid, Isocetyl Stearate, Butylene Glycol, C12-15 Alkyl Benzoate, Glyceryl Stearate, Dimethicone, Octyldodecyl Neopentanoate, Steareth-21, Silica, PEG-75 Stearate, Portulaca Oleracea Extract, Hydrolyzed Hibiscus Esculentus Extract, Hydrolyzed Wheat Protein, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Olea Europaea (Olive) Leaf Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Punica Granatum Extract, Daucus Carota Sativa (Carrot) Root Extract, Yeast Extract/Extrait De Levure, Panax Ginseng Root Extract, Padina Pavonica Extract, Retinol/Saccharomyces Polypeptide, Saxifraga Sarmentosa Extract, Vitis Vinifera (Grape) Fruit Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Plankton Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Medicago Sativa (Alfalfa) Extract, Phaeodactylum Tricornutum Extract, Tilia Cordata Wood Extract, Steareth-2, Ammonium Hydroxide, Nylon-12, Sodium Laureth Sulfate, PEG-12 Dimethicone, Magnesium Aluminum Silicate, Parfum/Fragrance, Paraffin, Xanthan Gum, Talc, Xymenynic Acid, Mannitol, Polymethyl Methacrylate, Phytol, Alumina, Glycogen, Oryzanol, PEG-40 Hydrogenated Castor Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Calcium Pantothenate, Biotin, Tocopherol, Disodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben. May Contain: Titanium Dioxide/CI 77891, Iron Oxides, Mica/CI 77019, Bismuth Oxychloride/CI 77163.

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  FOUNDATION
octinoxate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0171
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 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0171-2	1 in 1 CARTON
1	NDC: 10096-0171-1	30 mL in 1 BOTTLE, PUMP

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(10096-0171)