NDC 10157-9905 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

NDC Product Code 10157-9905

NDC Code: 10157-9905

Proprietary Name: Blistex Advanced Care (blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dimethicone, Octinoxate, Octisalate, Avobenzone, And Homosalate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 10157 - Blistex Inc
    • 10157-9905 - Blistex Advanced Care (blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother)

NDC 10157-9905-1

Package Description: 1 KIT in 1 CARTON * 4.25 g in 1 CYLINDER * 4.25 g in 1 CYLINDER * 4.25 g in 1 CYLINDER * 4.25 g in 1 CYLINDER

NDC Product Information

Blistex Advanced Care (blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) with NDC 10157-9905 is a a human over the counter drug product labeled by Blistex Inc. The generic name of Blistex Advanced Care (blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) is dimethicone, octinoxate, octisalate, avobenzone, and homosalate. The product's dosage form is kit and is administered via form.

Labeler Name: Blistex Inc

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • 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)
  • 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)
  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Blistex Inc
Labeler Code: 10157
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Blistex Advanced Care (blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) Product Label Images

Blistex Advanced Care (blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

FIVE STAR Lip Protection®Drug Facts

COMPLETE MOISTURE® SPF 15 MEDICATED BALM SPF 15 SUPERFRUIT SOOTHER® SPF 15Drug Facts

For external use only

Otc - Purpose

Active ingredientsPurposeAvobenzone 3.0% (w/w)SunscreenDimethicone 2.0% (w/w)Lip protectantHomosalate 10.0% (w/w)SunscreenOctinoxate 7.5% (w/w)SunscreenOctisalate 5.0% (w/w)Sunscreen

Active ingredientsPurposeDimethicone 2.0% (w/w)Lip protectantOctinoxate 6.6% (w/w)SunscreenOctisalate 4.4% (w/w)Sunscreen

Uses

  • Temporarily protects and helps relieve chapped or cracked lipshelps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Temporarily protects and helps relieve chapped or cracked lipshelps prevent sunburn

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Stop use and ask a doctor if rash occurs

Otc - When Using

When using this product keep out of eyes.Rinse with water to remove.

When using this product keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposurereapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months of age: Ask a doctorSun 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

  • Apply liberally 15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingchildren under 6 months of age: Ask a doctor

Other Information

  • Protect the product in this container from excessive heat and direct sun

  • Protect the product in this container from excessive heat and direct sun

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

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

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

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

* Please review the disclaimer below.