Your browser does not support JavaScript! ANEW AGE-TRANSFORMING FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LOTION [AVON PRODUCTS, INC]
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ANEW AGE-TRANSFORMING FOUNDATION (octinoxate, titanium dioxide) lotion
[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 7.50%.........................................................................
Titanium Dioxide 4.00%.................................................................

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:Water/Eau, Cyclopentasiloxane, Glycerin, Propylene Glycol Isoceteth-3 Acetate, Glycolic Acid, Isocetyl Stearate, Butylene Glycol, C12-15 Alkyl Benzoate, Glyceryl Stearate, Dimethicone, Octyldodecyl Neopentanoate, Steareth-21, Silica, PEG-75 Stearate, Portulaca Oleracea Extract, Hydrolyzed Hibiscus Esculentus Extract, Hydrolyzed Wheat Protein, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Olea Europaea (Olive) Leaf Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Punica Granatum Extract, Daucus Carota Sativa (Carrot) Root Extract, Yeast Extract/Extrait De Levure, Panax Ginseng Root Extract, Padina Pavonica Extract, Retinol/Saccharomyces Polypeptide, Saxifraga Sarmentosa Extract, Vitis Vinifera (Grape) Fruit Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Plankton Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Medicago Sativa (Alfalfa) Extract, Phaeodactylum Tricornutum Extract, Tilia Cordata Wood Extract, Steareth-2, Ammonium Hydroxide, Nylon-12, Sodium Laureth Sulfate, PEG-12 Dimethicone, Magnesium Aluminum Silicate, Parfum/Fragrance, Paraffin, Xanthan Gum, Talc, Xymenynic Acid, Mannitol, Polymethyl Methacrylate, Phytol, Alumina, Glycogen, Oryzanol, PEG-40 Hydrogenated Castor Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Calcium Pantothenate, Biotin, Tocopherol, Disodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben. 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 cartonimage of carton

ANEW AGE-TRANSFORMING  FOUNDATION
octinoxate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10096-0171
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE40 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0171-21 in 1 CARTON
1NDC:10096-0171-130 mL in 1 BOTTLE, PUMP
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(10096-0171)

Revised: 2/2013
 
Avon Products, Inc

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