EXTRALASTING CREAM-TO-POWDER FOUNDATION- octinoxate, titanium dioxide cream

Extralasting by

Drug Labeling and Warnings

Extralasting 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 6.34%...................................

Titanium Dioxide 3.00%............................

                            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: Propylene Glycol Dicaprylate/Dicaprate, Diisopropyl Dimer Dilinoleate, Microcrystalline Wax/Cire Microcristalline, Nylon-12, Cetyl Ricinoleate, Hydrogenated Coco-Glycerides, Silica, Tribehenin, Punica Granatum Sterols, Polymethyl Methacrylate, Ethylene/Methacrylate Copolymer, Propylparaben, VP/Hexadecene Copolymer, Dimethicone, Ethylparaben, Triethoxycaprylylsilane, Glyceryl Rosinate, Octyldodecyl Myristate, Magnesium Myristate, Butylparaben, Tocopheryl Acetate, Isopropyl Titanium Triisostearate. 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

EXTRALASTING  CREAM-TO-POWDER FOUNDATION
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	63.4 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0231-2	1 in 1 CARTON
1	NDC: 10096-0231-1	9 g in 1 CASE; 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	12/15/2010

Labeler - New Avon LLC (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc.		544863277	manufacture(10096-0231)