ENHANCEMENT SERIES (BLISTEX SOFT AND LUSH, BLISTEX DEEP RENEWAL, BLISTEX ULTRA-RICH HYDRATION)- dimethicone, octinoxate, octisalate, avobenzone, and oxybenzone kit
Enhancement Series (Blistex Soft and Lush, Blistex Deep Renewal, Blistex Ultra-Rich Hydration) by
Drug Labeling and Warnings
Enhancement Series (Blistex Soft and Lush, Blistex Deep Renewal, Blistex Ultra-Rich Hydration) 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
- 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, C12-15 alkyl benzoate, caprylic/capric triglyceride, ceramide NG, ceresin, cetyl dimethicone, cetyl palmitate, flavors, glyceryl laurate, hydrogenated castor oil, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, palmitoyl hexapeptide-12, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, titanium dioxide, tribehenin
- 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, flavors, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, pentylene glycol, petrolatum, phenoxyethanol, polybutene, 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
-
Inactive ingredients
alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, ceresin, cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, 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
ENHANCEMENT SERIES (BLISTEX SOFT AND LUSH, BLISTEX DEEP RENEWAL, BLISTEX ULTRA-RICH HYDRATION)
dimethicone, octinoxate, octisalate, avobenzone, and oxybenzone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 10157-9907 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 10157-9907-1 1 in 1 BLISTER PACK 12/16/2019 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 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 PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) PETROLATUM (UNII: 4T6H12BN9U) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PARAFFIN (UNII: I9O0E3H2ZE) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) CETYL PALMITATE (UNII: 5ZA2S6B08X) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) CERESIN (UNII: Q1LS2UJO3A) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) WHITE WAX (UNII: 7G1J5DA97F) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) GLYCERYL LAURATE (UNII: Y98611C087) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIBEHENIN (UNII: 8OC9U7TQZ0) CERAMIDE NG (UNII: C04977SRJ5) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SACCHARIN (UNII: FST467XS7D) 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 part352 12/16/2019 Part 2 of 3 BLISTEX DEEP RENEWAL BROAD SPECTRUM
dimethicone, avobenzone, 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 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 OCTYLDODECANOL (UNII: 461N1O614Y) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PETROLATUM (UNII: 4T6H12BN9U) CASTOR OIL (UNII: D5340Y2I9G) YELLOW WAX (UNII: 2ZA36H0S2V) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) ETHYLHEXYL PALMITATE (UNII: 2865993309) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) SQUALANE (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F) CHONDROITIN SULFATE SODIUM, SHARK (UNII: Q75WVO004L) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) PENTYLENE GLYCOL (UNII: 50C1307PZG) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIN (UNII: FST467XS7D) SORBIC ACID (UNII: X045WJ989B) 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 12/16/2019 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 6.6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.4 g in 100 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) PETROLATUM (UNII: 4T6H12BN9U) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PARAFFIN (UNII: I9O0E3H2ZE) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) CETYL PALMITATE (UNII: 5ZA2S6B08X) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) WHITE WAX (UNII: 7G1J5DA97F) CERESIN (UNII: Q1LS2UJO3A) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) OLIVE OIL (UNII: 6UYK2W1W1E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) COCOA BUTTER (UNII: 512OYT1CRR) SACCHARIN (UNII: FST467XS7D) SUNFLOWER OIL (UNII: 3W1JG795YI) CHAMOMILE (UNII: FGL3685T2X) WHEAT GERM OIL (UNII: 14C97E680P) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 part352 12/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 12/16/2019 Labeler - Blistex Inc (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc 005126354 MANUFACTURE(10157-9907)
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