BLISTEX ADVANCED CARE (BLISTEX MEDICATED BALM, BLISTEX COMPLETE MOISTURE, BLISTEX FIVE STAR LIP BALM - BROAD SPECTRUM, BLISTEX SUPERFRUIT SOOTHER)- dimethicone, octinoxate, octisalate, avobenzone, and homosalate kit
Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) by
Drug Labeling and Warnings
Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- temporarily protects and helps relieve chapped or cracked lips
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: Ask a doctor
-
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
- Other information
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Inactive ingredients
bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, calendula officinalis flower extract, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, helianthus annuus (sunflower) seed oil, microcrystalline wax, myristyl myristate, octyldodecanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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COMPLETE MOISTURE Inactive ingredients
behenoyl stearic acid, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavor, glycerin, hydrogenated phosphatidylcholine, jojoba esters, microcrystalline wax, ozokerite, panthenol, petrolatum, phenoxyethanol, purified water, sodium borate, sodium saccharin, squalane
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MEDICATED BALM Inactive ingredients
beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide
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SUPERFRUIT SOOTHER Inactive ingredients
beeswax, caprylic/capric triglyceride, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, euterpe oleracea (acai) fruit extract, flavor, isopropyl myristate, lanolin, lanolin oil, menthoxypropanediol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, rubus chamaemorus (cloudberry) fruit extract, saccharin, tetrahexyldecyl ascorbate, theobroma cacao (cocoa) seed butter, tocopheryl acetate
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
BLISTEX ADVANCED CARE (BLISTEX MEDICATED BALM, BLISTEX COMPLETE MOISTURE, BLISTEX FIVE STAR LIP BALM - BROAD SPECTRUM, BLISTEX SUPERFRUIT SOOTHER)
dimethicone, octinoxate, octisalate, avobenzone, and homosalate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 10157-9905 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 10157-9905-1 1 in 1 CARTON 08/26/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CYLINDER 4.25 g Part 2 1 CYLINDER 4.25 g Part 3 1 CYLINDER 4.25 g Part 4 1 CYLINDER 4.25 g Part 1 of 4 BLISTEX MEDICATED LIP BALM
dimethicone, octinoxate, and octisalate 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 6.6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.4 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) CERESIN (UNII: Q1LS2UJO3A) CANDELILLA WAX (UNII: WL0328HX19) LANOLIN OIL (UNII: OVV5IIJ58F) YELLOW WAX (UNII: 2ZA36H0S2V) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) CETYL PALMITATE (UNII: 5ZA2S6B08X) CETYL ALCOHOL (UNII: 936JST6JCN) PARAFFIN (UNII: I9O0E3H2ZE) COCOA BUTTER (UNII: 512OYT1CRR) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O) METHYL SALICYLATE (UNII: LAV5U5022Y) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 6 (UNII: 481744AI4O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.25 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 08/26/2019 Part 2 of 4 BLISTEX COMPLETE MOISTURE
dimethicone, octinoxate, and octisalate 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 6.6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.4 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) PETROLATUM (UNII: 4T6H12BN9U) CERESIN (UNII: Q1LS2UJO3A) 7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) SODIUM BORATE (UNII: 91MBZ8H3QO) PANTHENOL (UNII: WV9CM0O67Z) SQUALANE (UNII: GW89575KF9) CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 07PS463G0H) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.25 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 part352 08/26/2019 Part 3 of 4 BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM
dimethicone, avobenzone, homosalate, octinoxate, and octisalate 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 Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 g in 100 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 10 g in 100 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 g in 100 g Inactive Ingredients Ingredient Name Strength Microcrystalline Wax (UNII: XOF597Q3KY) Octyldodecanol (UNII: 461N1O614Y) Ceresin (UNII: Q1LS2UJO3A) Myristyl Myristate (UNII: 4042ZC00DY) Stearyl Behenate (UNII: A68S9UI39D) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) Bis-Diglyceryl Polyacyladipate-2 (UNII: 6L246LAM9T) CANDELILLA WAX (UNII: WL0328HX19) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) Phenoxyethanol (UNII: HIE492ZZ3T) SUNFLOWER OIL (UNII: 3W1JG795YI) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) WHEAT GERM OIL (UNII: 14C97E680P) SAFFLOWER OIL (UNII: 65UEH262IS) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBIC ACID (UNII: X045WJ989B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.25 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 08/26/2019 Part 4 of 4 BLISTEX SUPERFRUIT SOOTHER
dimethicone, octinoxate, and octisalate 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 6.6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.4 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) LANOLIN OIL (UNII: OVV5IIJ58F) YELLOW WAX (UNII: 2ZA36H0S2V) CERESIN (UNII: Q1LS2UJO3A) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) CANDELILLA WAX (UNII: WL0328HX19) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) CETYL PALMITATE (UNII: 5ZA2S6B08X) CETYL ALCOHOL (UNII: 936JST6JCN) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ACAI (UNII: 46AM2VJ0AW) RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6) PARAFFIN (UNII: I9O0E3H2ZE) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) SACCHARIN (UNII: FST467XS7D) PHENOXYETHANOL (UNII: HIE492ZZ3T) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.25 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 08/26/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 08/26/2019 Labeler - Blistex Inc (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc 005126354 MANUFACTURE(10157-9905)
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