Label: BLISTEX ENHANCEMENT SERIES (LIP VIBRANCE, DEEP RENEWAL AND ULTRA-RICH HYDRATION)- dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 10157-9861-1 - 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 June 26, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- LIP VIBRANCE®
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
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
- DEEP RENEWAL®
- ACTIVE INGREDIENT
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- 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 sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
- Other information
-
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
- ULTRA-RICH HYDRATION™
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
Inactive ingredients
aloe barbadensis leaf extract, alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea butter), ceresin, cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, isostearoyl hydrolyzed silk, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, theobroma cacao (cocoa) seed butter, titanium dioxide, tocopheryl acetate, triticum vulgare (wheat) germ oil
- PRINCIPAL DISPLAY PANEL - 3 Stick Blister Pack
-
INGREDIENTS AND APPEARANCE
BLISTEX ENHANCEMENT SERIES (LIP VIBRANCE, DEEP RENEWAL AND ULTRA-RICH HYDRATION)
dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9861 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9861-1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 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; Type 0: Not a Combination Product 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 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; Type 0: Not a Combination Product 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 ULTRA-RICH HYDRATION
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 6.8 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 3 g in 100 g Inactive Ingredients Ingredient Name Strength yellow wax (UNII: 2ZA36H0S2V) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) PETROLATUM (UNII: 4T6H12BN9U) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) microcrystalline wax (UNII: XOF597Q3KY) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SHEA BUTTER (UNII: K49155WL9Y) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL PALMITATE (UNII: 5ZA2S6B08X) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) OLIVE OIL (UNII: 6UYK2W1W1E) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHEAT GERM OIL (UNII: 14C97E680P) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SUNFLOWER OIL (UNII: 3W1JG795YI) CHAMOMILE (UNII: FGL3685T2X) ceresin (UNII: Q1LS2UJO3A) COCOA BUTTER (UNII: 512OYT1CRR) SACCHARIN (UNII: FST467XS7D) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3.69 g in 1 CYLINDER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 05/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/01/2014 Labeler - Blistex Inc. (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc. 005126354 MANUFACTURE(10157-9861)
