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Blistex

Blistex Inc.

Blistex Five Star Lip Protection Broad Spectrum


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Avobenzone 3.0% (w/w) Sunscreen
Dimethicone 2.0% (w/w) Lip protectant
Homosalate 4.5% (w/w) Sunscreen
Octinoxate 7.5% (w/w) Sunscreen
Octisalate 5.0% (w/w) Sunscreen
Octocrylene 2.7% (w/w) Sunscreen
Oxybenzone 6.0% (w/w) Sunscreen

Blistex 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 this product from excessive heat and direct sun

Inactive ingredients

calendula officinalis (marigold) flower extract, carthamus tinctorius (safflower) seed oil, euphorbia cerifera (candelilla) wax, flavor, helianthus annuus (sunflower) seed oil, hydrogenated coconut oil, jojoba esters, microcrystalline wax, myristyl myristate, octyldodecanol, panthenol, phenoxyethanol, polyethylene, PTFE, sorbic acid, stearyl behenate, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton

NDC 10157-9842-1

Blistex ®
LIP PROTECTANT/
SUNSCREEN

FIVE STAR
Lip Protection
®

NET WT. .15 oz (4.25g)

For Dryness, Cold, Heat, Wind & Sun

Blistex

Blistex

Octinoxate, Oxybenzone, Dimethicone, Octisalate, Homosalate, Avobenzone, and Octocrylene STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10157-9842
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 g
OXYBENZONE OXYBENZONE 6 g
DIMETHICONE 2 g
OCTISALATE OCTISALATE 5 g
HOMOSALATE Homosalate 4.5 g
AVOBENZONE AVOBENZONE 3 g
OCTOCRYLENE Octocrylene 2.7 g

Inactive Ingredients

Ingredient Name Strength
CALENDULA OFFICINALIS FLOWER
SAFFLOWER OIL
CANDELILLA WAX
SUNFLOWER OIL
HYDROGENATED COCONUT OIL
MICROCRYSTALLINE WAX
MYRISTYL MYRISTATE
OCTYLDODECANOL
PANTHENOL
PHENOXYETHANOL
HIGH DENSITY POLYETHYLENE
polytetrafluoroethylene
sorbic acid
stearyl behenate
TETRAHEXYLDECYL ASCORBATE
.ALPHA.-TOCOPHEROL ACETATE
WHEAT GERM OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 4.25 in 1 CYLINDER
2 NDC:10157-9842-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2013-04-15


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