Label: IDEAL FLAWLESS BEAUTY BALM- titantium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0293-1, 10096-0293-2 - Packager: New Avon LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: 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 Information
Updated February 17, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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 - STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive/Non-Medicinal Ingredients:
Water/Eau, Cyclopentasiloxane, Phenyl Trimethicone, Glycerin, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Trifluoromethyl C1-4 Alkyl Dimethicone, Nylon-12, Octyldodecyl Neopentanoate, Polysilicone-11, Quaternium-90 Bentonite, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Octyldodecyl Stearoyl Stearate, Phenoxyethanol, Methyl Undecylenate, Ethyl Undecylenate, HDI/Trimethylol Hexyllactone Crosspolymer, Tetrasodium EDTA, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Propylene Carbonate,
Hexylene Glycol, Calcium PCA, Zinc PCA, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Methicone, Cocos Nucifera (Coconut) Fruit Juice, Silica, Tocopheryl Acetate, Saccharomyces/Copper Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Saccharomyces/Malachite Ferment, Saccharomyces/Tourmaline Ferment. May Contain: Titanium Dioxide/CI 77891, Iron Oxides, Mica/CI 77019. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IDEAL FLAWLESS BEAUTY BALM
titantium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0293 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 54 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0293-2 1 in 1 CARTON 1 NDC:10096-0293-1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/19/2013 Labeler - New Avon LLC (080143520) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0293)
