Your browser does not support JavaScript! EXTRALASTING CREAM-TO-POWDER FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) CREAM [AVON PRODUCTS, INC.]
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EXTRALASTING CREAM-TO-POWDER FOUNDATION (octinoxate, titanium dioxide) cream
[Avon Products, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

image of PDPimage of DFBimage of DFB

EXTRALASTING  CREAM-TO-POWDER FOUNDATION
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0231
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE63.4 mg  in 1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE30 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:10096-0231-21 in 1 CARTON
1NDC:10096-0231-19 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/15/2010
Labeler - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Products, Inc.544863277manufacture(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.

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