Label: BLISTEX ENHANCEMENT SERIES (SOFT AND LUSH, DEEP RENEWAL AND ULTRA-RICH HYDRATION)- dimethicone, octinoxate, oxybenzone, avobenzone and octocrylene kit
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Contains inactivated NDC Code(s)
NDC Code(s): 10157-9867-1 - 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 August 28, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, ceramide NG, ceresin, cetyl dimethicone, cetyl palmitate, flavors, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, microcrystalline wax, paraffin, PEG-8, PEG-60 hydrogenated castor oil, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, titanium dioxide
- 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
aloe barbadensis leaf extract (decolorized), 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 - Kit Blister Pack
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INGREDIENTS AND APPEARANCE
BLISTEX ENHANCEMENT SERIES (SOFT AND LUSH, DEEP RENEWAL AND ULTRA-RICH HYDRATION)
dimethicone, octinoxate, oxybenzone, avobenzone and octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9867 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9867-1 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 SOFT AND LUSH
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 PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PETROLATUM (UNII: 4T6H12BN9U) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PARAFFIN (UNII: I9O0E3H2ZE) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) YELLOW WAX (UNII: 2ZA36H0S2V) CERESIN (UNII: Q1LS2UJO3A) CETYL PALMITATE (UNII: 5ZA2S6B08X) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) CERAMIDE 2 (UNII: C04977SRJ5) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIN (UNII: FST467XS7D) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) 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 08/01/2015 Part 2 of 3 BLISTEX DEEP RENEWAL
dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene 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 08/01/2015 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 08/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 07/01/2015 Labeler - Blistex Inc. (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc. 005126354 MANUFACTURE(10157-9867)
