BLISTEX  FIVE STAR LIP PROTECTION BROAD SPECTRUM- homosalate, octisalate, avobenzone, and dimethicone 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 15.0 % (w/w)Sunscreen
Octisalate 5.0 % (w/w)Sunscreen

Uses

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

Other information

Inactive ingredients

bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, butyloctyl salicylate, C12-15 alkyl benzoate, calendula officinalis extract, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, microcrystalline wax, myristyl myristate, octyldodecanol, oryzanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack

The Ultimate
Daily Protection
For Lips

Blistex®

FIVE STAR
Lip Protection®

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack
BLISTEX   FIVE STAR LIP PROTECTION BROAD SPECTRUM
homosalate, octisalate, avobenzone, and dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1171
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate15 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
CERESIN (UNII: Q1LS2UJO3A)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
STEARYL BEHENATE (UNII: A68S9UI39D)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
CANDELILLA WAX (UNII: WL0328HX19)  
ORYZANOL (UNII: SST9XCL51M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
WHEAT GERM OIL (UNII: 14C97E680P)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SORBIC ACID (UNII: X045WJ989B)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-1171-11 in 1 BLISTER PACK08/22/2020
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:10157-1171-22 in 1 BLISTER PACK08/22/2020
24.25 g in 1 CYLINDER; Type 0: Not a Combination Product
3NDC:10157-1171-33 in 1 BLISTER PACK08/22/2020
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 finalpart35208/22/2020
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-1171)

Revised: 8/2020
Document Id: 7f00e804-2e2b-4dbf-8ceb-9e526785046a
Set id: 47b57317-7df5-442e-a3a4-1d44fe278ac6
Version: 1
Effective Time: 20200825
 
Blistex Inc.