Label: ANEW AGE-TRANSFORMING CONCEALER- titanium dioxide and octinoxate cream
- NDC Code(s): 10096-0138-1, 10096-0138-2
- 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.
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- ACTIVE INGREDIENT
Titanium Dioxide 6.62%.........................
- INDICATIONS & USAGE
- helps prevent sunburn
For external use only
Do not use on damaged or broken skin
- DOSAGE & ADMINISTRATION
- 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
- STORAGE AND HANDLING
- protect the product in this container from excessive heat and direct sun
- INACTIVE INGREDIENT
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,Close
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.
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- INGREDIENTS AND APPEARANCE
ANEW AGE-TRANSFORMING CONCEALER
titanium dioxide, octinoxate cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10096-0138 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 66.2 mg in 1 g OCTINOXATE (OCTINOXATE) OCTINOXATE 25 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0138-2 1 in 1 CARTON 1 NDC:10096-0138-1 1.7 g in 1 VIAL, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/09/2013 Labeler - Avon Products, Inc (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0138)