Label: AVON TRUE COLOR FLAWLESS CREAM TO POWDER FOUNDATION- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71110-0007-1, 71110-0007-2 - Packager: Avon Products, Inc.
- 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 December 14, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
For sunscreen use:
• 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 Ingredients: PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIISOPROPYL DIMER DILINOLEATE, MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE, CALCIUM SODIUM BOROSILICATE, CETYL RICINOLEATE, HYDROGENATED COCO-GLYCERIDES, SILICA, TRIBEHENIN, POLYMETHYL METHACRYLATE, ETHYLENE/METHACRYLATE COPOLYMER, ETHYLPARABEN, METHYLPARABEN, MAGNESIUM MYRISTATE, HYDRATED SILICA, ALUMINA, DIMETHICONE, ISOPROPYL TITANIUM TRIISOSTEARATE, BORON NITRIDE, CETEARYL DIMETHICONE CROSSPOLYMER, CAPRYLYL METHICONE, PEG/PPG-20/23 DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, KAOLIN. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE/CI 77891, MICA/CI 77019, BLUE 1 LAKE/CI 42090, BISMUTH OXYCHLORIDE/CI 77163
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVON TRUE COLOR FLAWLESS CREAM TO POWDER FOUNDATION
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71110-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 63.1 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31.6 mg in 1 g Inactive Ingredients Ingredient Name Strength TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MICA (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) HYDRATED SILICA (UNII: Y6O7T4G8P9) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG/PPG-20/23 DIMETHICONE (UNII: XK68QT7HWY) KAOLIN (UNII: 24H4NWX5CO) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) MAGNESIUM MYRISTATE (UNII: Z1917F0578) TRIBEHENIN (UNII: 8OC9U7TQZ0) CETYL RICINOLEATE (UNII: 1P677500YD) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71110-0007-2 1 in 1 CARTON 12/19/2017 1 NDC:71110-0007-1 9 g in 1 CASE; 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 12/19/2017 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc. 544863277 manufacture(71110-0007)