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

Blistex Five Star Lip Protection Broad Spectrum by

Drug Labeling and Warnings

Blistex Five Star Lip Protection Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1107
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
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1107-1	1 in 1 CARTON	05/01/2016
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1107-2	2 in 1 CARTON	05/01/2016
2		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
3	NDC: 10157-1107-3	3 in 1 CARTON	05/01/2016
3		4.25 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	05/01/2016

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-1107)