BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM- dimethicone, avobenzone, homosalate, octinoxate, and octisalate stick 
Blistex Inc

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.

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Blistex® Five Star Lip Protection® Broad Spectrum

Drug Facts

Active ingredientsPurpose
Avobenzone 3.0% (w/w)Sunscreen
Dimethicone 2.0% (w/w)Lip protectant
Homosalate 10.0% (w/w)Sunscreen
Octinoxate 7.5% (w/w)Sunscreen
Octisalate 5.0% (w/w)Sunscreen

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

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

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 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

  • 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

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

Blistex®
LIP PROTECTANT/SUNSCREEN

FIVE STAR
Lip Protection®

☆
Holds in moisture in dry air
☆
Soothes cold-chapped lips
☆
Forms a wind-resistant moisture shield
☆
Rehydrates heat-stressed lips
☆
Protects from the sun

BROAD
SPECTRUM
SPF 30

WATER RESISTANT
(80 Minutes)

Net Wt. 0.15 oz.
(4.25 g)

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton
BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM 
dimethicone, avobenzone, homosalate, octinoxate, and octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-1107-11 in 1 CARTON05/01/201608/18/2020
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:10157-1107-22 in 1 CARTON05/01/201608/18/2020
24.25 g in 1 CYLINDER; Type 0: Not a Combination Product
3NDC:10157-1107-33 in 1 CARTON05/01/201608/18/2020
34.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/01/201608/18/2020
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-1107)

Revised: 8/2020
Document Id: 6cead3cf-26f8-4b44-849e-76fcd2dc1651
Set id: 67e12c22-ca09-4b1f-8ca8-79f7fe008849
Version: 3
Effective Time: 20200819
 
Blistex Inc