Label: FRUIT SMOOTHIES- dimethicone, octinoxate, and oxybenzone kit
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Contains inactivated NDC Code(s)
NDC Code(s): 10157-9883-3 - Packager: Blistex Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 18, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
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Inactive ingredients
alumina, bis-PEG-12 dimethicone beeswax, butylparaben, C20-40 pareth-3, ethylparaben, flavors, fruit extracts, glycerin, glyceryl stearate, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, lecithin, methylparaben, microcrystalline wax, myristyl myristate, ozokerite, panthenol, pantothenic acid polypeptide, polybutene, polyhydroxystearic acid, propylparaben, purified water, silica, sodium saccharin, squalane, sucralose, tetrahexyldecyl ascorbate, titanium dioxide, tridecyl neopentanoate, triisononanoin May contain: blue 1 lake, red 30 lake, yellow 10.
- Other information
- PRINCIPAL DISPLAY PANEL - Kit Blister Pack
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INGREDIENTS AND APPEARANCE
FRUIT SMOOTHIES
dimethicone, octinoxate, and oxybenzone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9883 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9883-3 1 in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CYLINDER 2.83 g Part 2 1 CYLINDER 2.83 g Part 3 1 CYLINDER 2.83 g Part 1 of 3 FRUIT SMOOTHIES MELON MEDLEY
dimethicone, octinoxate, and oxybenzone stickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 2 g in 100 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength aluminum oxide (UNII: LMI26O6933) C20-40 pareth-3 (UNII: 68103A23TQ) glycerin (UNII: PDC6A3C0OX) glyceryl monostearate (UNII: 230OU9XXE4) hydrogenated castor oil (UNII: ZF94AP8MEY) isopropyl myristate (UNII: 0RE8K4LNJS) microcrystalline wax (UNII: XOF597Q3KY) myristyl myristate (UNII: 4042ZC00DY) panthenol (UNII: WV9CM0O67Z) TRIISONONANOIN (UNII: XF4K22WN6T) silicon dioxide (UNII: ETJ7Z6XBU4) saccharin sodium (UNII: SB8ZUX40TY) squalane (UNII: GW89575KF9) sucralose (UNII: 96K6UQ3ZD4) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) titanium dioxide (UNII: 15FIX9V2JP) tridecyl neopentanoate (UNII: 3Z8H1DA7J5) water (UNII: 059QF0KO0R) FD&C blue no. 1 (UNII: H3R47K3TBD) D&C yellow no. 10 (UNII: 35SW5USQ3G) ceresin (UNII: Q1LS2UJO3A) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2.83 g in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 06/14/2013 Part 2 of 3 FRUIT SMOOTHIES TRIPLE TROPICAL
dimethicone, octinoxate, and oxybenzone stickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 2 g in 100 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength aluminum oxide (UNII: LMI26O6933) C20-40 pareth-3 (UNII: 68103A23TQ) glycerin (UNII: PDC6A3C0OX) glyceryl monostearate (UNII: 230OU9XXE4) hydrogenated castor oil (UNII: ZF94AP8MEY) isopropyl myristate (UNII: 0RE8K4LNJS) microcrystalline wax (UNII: XOF597Q3KY) myristyl myristate (UNII: 4042ZC00DY) panthenol (UNII: WV9CM0O67Z) TRIISONONANOIN (UNII: XF4K22WN6T) silicon dioxide (UNII: ETJ7Z6XBU4) saccharin sodium (UNII: SB8ZUX40TY) squalane (UNII: GW89575KF9) sucralose (UNII: 96K6UQ3ZD4) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) titanium dioxide (UNII: 15FIX9V2JP) tridecyl neopentanoate (UNII: 3Z8H1DA7J5) water (UNII: 059QF0KO0R) D&C red no. 30 (UNII: 2S42T2808B) D&C yellow no. 10 (UNII: 35SW5USQ3G) ceresin (UNII: Q1LS2UJO3A) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2.83 g in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 06/14/2013 Part 3 of 3 FRUIT SMOOTHIES BERRY EXPLOSION
dimethicone, octinoxate, and oxybenzone stickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 2 g in 100 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength aluminum oxide (UNII: LMI26O6933) C20-40 pareth-3 (UNII: 68103A23TQ) glycerin (UNII: PDC6A3C0OX) glyceryl monostearate (UNII: 230OU9XXE4) hydrogenated castor oil (UNII: ZF94AP8MEY) isopropyl myristate (UNII: 0RE8K4LNJS) microcrystalline wax (UNII: XOF597Q3KY) myristyl myristate (UNII: 4042ZC00DY) panthenol (UNII: WV9CM0O67Z) TRIISONONANOIN (UNII: XF4K22WN6T) silicon dioxide (UNII: ETJ7Z6XBU4) saccharin sodium (UNII: SB8ZUX40TY) squalane (UNII: GW89575KF9) sucralose (UNII: 96K6UQ3ZD4) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) titanium dioxide (UNII: 15FIX9V2JP) tridecyl neopentanoate (UNII: 3Z8H1DA7J5) water (UNII: 059QF0KO0R) FD&C blue no. 1 (UNII: H3R47K3TBD) D&C red no. 30 (UNII: 2S42T2808B) ceresin (UNII: Q1LS2UJO3A) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2.83 g in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 06/14/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 06/14/2013 Labeler - Blistex Inc. (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc. 005126354 MANUFACTURE(10157-9883)