Your browser does not support JavaScript! ANEW AGE-TRANSFORMING CONCEALER (TITANIUM DIOXIDE, OCTINOXATE) CREAM [AVON PRODUCTS, INC]
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ANEW AGE-TRANSFORMING CONCEALER (titanium dioxide, octinoxate) 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
Titanium Dioxide 6.62%.........................
Octinoxate 2.50%.................................

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:Water/Eau, Butylene Glycol, Propylene Glycol Dicaprylate/Dicaprate, Cyclopentasiloxane, Glycolic Acid, Polysorbate 60, Glycol Stearate, PPG-2 Myristyl Ether Propionate, Silica, Sorbitan Stearate, Foeniculum Vulgare (Fennel) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Vitis Vinifera (Grape) Fruit Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Olea Europaea (Olive) Leaf Extract, Medicago Sativa (Alfalfa) Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Punica Granatum Extract,
Hydrolyzed Hibiscus Esculentus Extract, Portulaca Oleracea Extract, Saxifraga Sarmentosa Extract, Tilia Cordata Wood Extract, Panax Ginseng Root Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Yeast Extract/Extrait De Levure, Padina Pavonica Thallus Extract, Hydrolyzed Wheat Protein, Talc, Nylon-12, PEG-12 Dimethicone, Ammonium Hydroxide, Magnesium Aluminum Silicate, Paraffin, Xanthan Gum, Xymenynic Acid, Mannitol, Polymethyl Methacrylate, Phytol, Alumina, Glycogen, PEG-40 Hydrogenated Castor Oil, Calcium Pantothenate, Biotin, Tetrasodium EDTA, Imidazolidinyl Urea, Propylparaben, Methylparaben, Aluminum Hydroxide. May Contain: Iron Oxides, Mica, Bismuth Oxychloride, Titanium Dioxide.

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

image of PDPimage of carton

ANEW AGE-TRANSFORMING  CONCEALER
titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10096-0138
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE66.2 mg  in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE25 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0138-21 in 1 CARTON
1NDC:10096-0138-11.7 g in 1 VIAL, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/09/2013
Labeler - Avon Products, Inc (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Products, Inc005149471manufacture(10096-0138)

Revised: 2/2013
 
Avon Products, Inc

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