- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
alumina, beeswax, blue 1 lake1, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, isopropyl palmitate, isopropyl stearate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyethylene, polyhydroxystearic acid, red 30 lake1, saccharin, silica, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate, yellow 101
- 1
- May contain one or more of these ingredients.
- 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:10157-8010 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-8010-1 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 4 1 CYLINDER 2.83 g Part 1 of 4 FRUIT SMOOTHIES STRAWBERRY BANANA
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 1 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) yellow wax (UNII: 2ZA36H0S2V) diethylhexyl adipate (UNII: MBY1SL921L) glyceryl monostearate (UNII: 230OU9XXE4) ethylhexyl palmitate (UNII: 2865993309) isopropyl myristate (UNII: 0RE8K4LNJS) microcrystalline wax (UNII: XOF597Q3KY) myristyl myristate (UNII: 4042ZC00DY) phenoxyethanol (UNII: HIE492ZZ3T) ethylhexyl stearate (UNII: EG3PA2K3K5) silicon dioxide (UNII: ETJ7Z6XBU4) hydrogenated coconut oil (UNII: JY81OXM1OM) isopropyl palmitate (UNII: 8CRQ2TH63M) isopropyl stearate (UNII: 43253ZW1MZ) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) titanium dioxide (UNII: 15FIX9V2JP) phenyl trimethicone (UNII: DR0K5NOJ4R) high density polyethylene (UNII: UG00KM4WR7) saccharin (UNII: FST467XS7D) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) Product Characteristics Color WHITE 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 09/01/2013 Part 2 of 4 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 1 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) yellow wax (UNII: 2ZA36H0S2V) diethylhexyl adipate (UNII: MBY1SL921L) glyceryl monostearate (UNII: 230OU9XXE4) ethylhexyl palmitate (UNII: 2865993309) isopropyl myristate (UNII: 0RE8K4LNJS) microcrystalline wax (UNII: XOF597Q3KY) myristyl myristate (UNII: 4042ZC00DY) phenoxyethanol (UNII: HIE492ZZ3T) ethylhexyl stearate (UNII: EG3PA2K3K5) silicon dioxide (UNII: ETJ7Z6XBU4) hydrogenated coconut oil (UNII: JY81OXM1OM) isopropyl palmitate (UNII: 8CRQ2TH63M) isopropyl stearate (UNII: 43253ZW1MZ) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) titanium dioxide (UNII: 15FIX9V2JP) phenyl trimethicone (UNII: DR0K5NOJ4R) high density polyethylene (UNII: UG00KM4WR7) D&C red no. 30 (UNII: 2S42T2808B) D&C yellow no. 10 (UNII: 35SW5USQ3G) saccharin (UNII: FST467XS7D) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) Product Characteristics Color ORANGE 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 09/01/2013 Part 3 of 4 FRUIT SMOOTHIES SUMMER SWEET FRUIT
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 1 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) yellow wax (UNII: 2ZA36H0S2V) diethylhexyl adipate (UNII: MBY1SL921L) glyceryl monostearate (UNII: 230OU9XXE4) ethylhexyl palmitate (UNII: 2865993309) isopropyl myristate (UNII: 0RE8K4LNJS) microcrystalline wax (UNII: XOF597Q3KY) myristyl myristate (UNII: 4042ZC00DY) phenoxyethanol (UNII: HIE492ZZ3T) ethylhexyl stearate (UNII: EG3PA2K3K5) silicon dioxide (UNII: ETJ7Z6XBU4) hydrogenated coconut oil (UNII: JY81OXM1OM) isopropyl palmitate (UNII: 8CRQ2TH63M) isopropyl stearate (UNII: 43253ZW1MZ) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) titanium dioxide (UNII: 15FIX9V2JP) phenyl trimethicone (UNII: DR0K5NOJ4R) high density polyethylene (UNII: UG00KM4WR7) FD&C blue no. 1 (UNII: H3R47K3TBD) D&C yellow no. 10 (UNII: 35SW5USQ3G) saccharin (UNII: FST467XS7D) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) 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 09/01/2013 Part 4 of 4 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 1 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) yellow wax (UNII: 2ZA36H0S2V) diethylhexyl adipate (UNII: MBY1SL921L) glyceryl monostearate (UNII: 230OU9XXE4) ethylhexyl palmitate (UNII: 2865993309) isopropyl myristate (UNII: 0RE8K4LNJS) microcrystalline wax (UNII: XOF597Q3KY) myristyl myristate (UNII: 4042ZC00DY) phenoxyethanol (UNII: HIE492ZZ3T) ethylhexyl stearate (UNII: EG3PA2K3K5) silicon dioxide (UNII: ETJ7Z6XBU4) hydrogenated coconut oil (UNII: JY81OXM1OM) isopropyl palmitate (UNII: 8CRQ2TH63M) isopropyl stearate (UNII: 43253ZW1MZ) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) titanium dioxide (UNII: 15FIX9V2JP) phenyl trimethicone (UNII: DR0K5NOJ4R) high density polyethylene (UNII: UG00KM4WR7) FD&C blue no. 1 (UNII: H3R47K3TBD) D&C red no. 30 (UNII: 2S42T2808B) saccharin (UNII: FST467XS7D) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) 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 09/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 09/01/2013 Labeler - Blistex Inc. (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc. 005126354 MANUFACTURE(10157-8010)