Label: IDEAL FLAWLESS BEAUTY BALM- titanium dioxide cream
- NDC Code(s): 10096-0293-1, 10096-0293-2
- 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 5.40% W/W................................
- 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 sunClose
- INACTIVE INGREDIENT
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.
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- INGREDIENTS AND APPEARANCE
IDEAL FLAWLESS BEAUTY BALM
titantium dioxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0293 Route of Administration TOPICAL DEA Schedule 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/19/2013 Labeler - Avon Products, Inc (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0293)