EXTRALASTING CREAM-TO-POWDER FOUNDATION- octinoxate and titanium dioxide cream 
Avon Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Octinoxate 6.34%...................................

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

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

Uses
• helps prevent sunburn

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.

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

Other information
• protect the product in this container from excessive heat and direct sun

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

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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 DEA Schedule     
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
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/15/2010
Labeler - Avon Products, Inc. (001468693)
Establishment
Name Address ID/FEI Business Operations
Avon Products, Inc. 544863277 manufacture(10096-0231)

Revised: 10/2012
Document Id: b1b7ecd3-cd5e-4412-af47-66dce5bd068f
Set id: 0f22a716-7eac-4933-bdc3-5ea5659f9ff3
Version: 4
Effective Time: 20121016
 
Avon Products, Inc.