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 New Avon LLC, 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

For sunscreen use:
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, STEARETH-2, AMMONIUM HYDROXIDE, NYLON-12, PHENOXYETHANOL, SODIUM LAURETH SULFATE, PEG-12 DIMETHICONE, MAGNESIUM ALUMINUM SILICATE, PARFUM/FRAGRANCE, METHYLPARABEN, PARAFFIN, DISODIUM EDTA, ETHYLPARABEN, XANTHAN GUM, TALC, PORTULACA OLERACEA EXTRACT, XYMENYNIC ACID, HYDROLYZED HIBISCUS ESCULENTUS EXTRACT, HYDROLYZED WHEAT PROTEIN, MANNITOL, POLYMETHYL METHACRYLATE, PHYTOL, ALUMINA, GLYCOGEN, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT, ORYZANOL, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, FOENICULUM VULGARE (FENNEL) FRUIT EXTRACT, PUNICA GRANATUM EXTRACT, YEAST EXTRACT/EXTRAIT DE LEVURE, PANAX GINSENG ROOT EXTRACT, PADINA PAVONICA EXTRACT, PEG-40 HYDROGENATED CASTOR OIL, RETINOL/SACCHAROMYCES POLYPEPTIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SAXIFRAGA SARMENTOSA EXTRACT, VITIS VINIFERA (GRAPE) FRUIT EXTRACT, CAPRYLYL GLYCOL, TILIA CORDATA WOOD EXTRACT, CALCIUM PANTOTHENATE, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT, PLANKTON EXTRACT, BIOTIN, MORUS NIGRA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, MEDICAGO SATIVA (ALFALFA) EXTRACT, PHAEODACTYLUM TRICORNUTUM EXTRACT, TOCOPHEROL. MAY CONTAIN:TITANIUM DIOXIDE /CI 77891, IRON OXIDES, MICA/CI 77019.

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: 10096-0324
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: 10096-0324-2	1 in 1 CARTON
1	NDC: 10096-0324-1	30 mL in 1 BOTTLE, PUMP; 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	12/19/2014

Labeler - New Avon LLC (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc		005149471	manufacture(10096-0324)