Label: EXTRALASTING CREAM-TO-POWDER FOUNDATION- octinoxate and titanium dioxide cream
- NDC Code(s): 10096-0231-1, 10096-0231-2
- Packager: Avon Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 16, 2012
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
Titanium Dioxide 3.00%............................Close
- INDICATIONS & USAGE
• helps prevent sunburn
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
Directions• limit time in the sun, especially from 10 a.m. – 2 p.m.
• 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:
• wear long-sleeved shirts, pants, hats, and sunglassesClose
- STORAGE AND HANDLING
• 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.Close
Questions or Comments? Call toll free 1-800-FOR-AVON or 1-800-265-AVON in CanadaClose
- 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 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)