Label: BLISTEX ENHANCEMENT SERIES- dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene kit
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Contains inactivated NDC Code(s)
NDC Code(s): 10157-9858-1 - 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 April 23, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
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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 sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavor, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, petrolatum, phenoxyethanol, polybutene, polyethylene, PTFE, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, butylene glycol, butyrospermum parkii (shea butter), D&C red no. 6, D&C red no. 7, ethylhexyl palmitate, flavors, hydrogenated polyisobutene, iron oxides, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, polyethylene, PPG-5-ceteth-20, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium hyaluronate, titanium dioxide, tocopheryl acetate, vitis vinifera (grape) seed oil
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
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
- PRINCIPAL DISPLAY PANEL - 3 Stick Blister Pack
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INGREDIENTS AND APPEARANCE
BLISTEX ENHANCEMENT SERIES
dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9858 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9858-1 1 in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CYLINDER 3.69 g Part 2 1 CYLINDER 3.69 g Part 3 1 CYLINDER 3.69 g Part 1 of 3 BLISTEX LIP VIBRANCE
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 arachidyl alcohol (UNII: 1QR1QRA9BU) ceresin (UNII: Q1LS2UJO3A) paraffin (UNII: I9O0E3H2ZE) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) mineral oil (UNII: T5L8T28FGP) arachidyl glucoside (UNII: 6JVW35JOOJ) docosanol (UNII: 9G1OE216XY) butylene glycol (UNII: 3XUS85K0RA) shea butter (UNII: K49155WL9Y) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 6 (UNII: 481744AI4O) ethylhexyl palmitate (UNII: 2865993309) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) panthenyl ethyl ether (UNII: F4WMF8NX3B) pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897) high density polyethylene (UNII: UG00KM4WR7) PPG-5-ceteth-20 (UNII: 4AAN25P8P4) ferric oxide red (UNII: 1K09F3G675) titanium dioxide (UNII: 15FIX9V2JP) phenyl trimethicone (UNII: DR0K5NOJ4R) grape seed oil (UNII: 930MLC8XGG) castor oil (UNII: D5340Y2I9G) sandalwood (UNII: 3641YW25N2) saccharin (UNII: FST467XS7D) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) silica dimethyl silylate (UNII: EU2PSP0G0W) hyaluronate sodium (UNII: YSE9PPT4TH) Polybutene (1400 MW) (UNII: 1NA5AO9GH7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 part347 05/31/2013 Part 2 of 3 BLISTEX SILK AND SHINE
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 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) sandalwood (UNII: 3641YW25N2) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) Ceresin (UNII: Q1LS2UJO3A) Polybutene (1400 MW) (UNII: 1NA5AO9GH7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 part347 11/01/2012 Part 3 of 3 BLISTEX DEEP RENEWAL
avobenzone, octinoxate, octocrylene, oxybenzone, and dimethicone 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 Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength yellow wax (UNII: 2ZA36H0S2V) butylene glycol (UNII: 3XUS85K0RA) dipalmitoyl hydroxyproline (UNII: E6AHA53N1H) ethylhexyl palmitate (UNII: 2865993309) lanolin alcohols (UNII: 884C3FA9HE) microcrystalline wax (UNII: XOF597Q3KY) octyldodecanol (UNII: 461N1O614Y) pentaerythrityl tetraisostearate (UNII: 9D7IK5483F) petrolatum (UNII: 4T6H12BN9U) phenoxyethanol (UNII: HIE492ZZ3T) high density polyethylene (UNII: UG00KM4WR7) polytetrafluoroethylene (UNII: E1NC1JVS3O) castor oil (UNII: D5340Y2I9G) saccharin (UNII: FST467XS7D) silica dimethyl silylate (UNII: EU2PSP0G0W) hyaluronate sodium (UNII: YSE9PPT4TH) sorbic acid (UNII: X045WJ989B) squalane (UNII: GW89575KF9) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) Polybutene (1400 MW) (UNII: 1NA5AO9GH7) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) CHONDROITIN SULFATE SODIUM (SHARK) (UNII: Q75WVO004L) UBIDECARENONE (UNII: EJ27X76M46) SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 part347 11/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/15/2014 Labeler - Blistex Inc. (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc. 005126354 MANUFACTURE(10157-9858)