Label: SILK AND SHINE- dimethicone, octinoxate, and oxybenzone stick
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Contains inactivated NDC Code(s)
NDC Code(s): 10157-9882-1 - 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 October 17, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
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Inactive ingredients
arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, flavors, hydrogenated polyisobutene, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, PPG-5-Ceteth-20, saccharin, titanium dioxide, tocopheryl acetate
- Other information
- PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack
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INGREDIENTS AND APPEARANCE
SILK AND SHINE
dimethicone, octinoxate, and oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9882 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 arachidyl alcohol (UNII: 1QR1QRA9BU) arachidyl glucoside (UNII: 6JVW35JOOJ) docosanol (UNII: 9G1OE216XY) mica (UNII: V8A1AW0880) microcrystalline wax (UNII: XOF597Q3KY) mineral oil (UNII: T5L8T28FGP) panthenyl ethyl ether (UNII: F4WMF8NX3B) paraffin (UNII: I9O0E3H2ZE) pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897) petrolatum (UNII: 4T6H12BN9U) phenoxyethanol (UNII: HIE492ZZ3T) phenyl trimethicone (UNII: DR0K5NOJ4R) PPG-5-Ceteth-20 (UNII: 4AAN25P8P4) saccharin (UNII: FST467XS7D) titanium dioxide (UNII: 15FIX9V2JP) isopropyl behenate (UNII: 1BWO0L9BHI) Ceresin (UNII: Q1LS2UJO3A) Polybutene (1400 MW) (UNII: 1NA5AO9GH7) Silk, Acid Hydrolyzed (1000 MW) (UNII: 8549W658QV) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9882-1 1 in 1 BLISTER PACK 1 3.69 g in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/01/2012 Labeler - Blistex Inc (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc 005126354 MANUFACTURE(10157-9882)