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Blistex

Blistex Inc.

Blistex Medicated Lip Balm


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Dimethicone 2.0% (w/w) Lip protectant
Oxybenzone 2.5% (w/w) Sunscreen
Padimate O 6.6% (w/w) Sunscreen

Blistex Uses

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Warnings

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.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs

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 at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Inactive ingredients

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, lanolin oil, menthol, methylparaben, mineral oil, ozokerite, paraffin, petrolatum, polybutene, propylparaben, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

Blistex Other information

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

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack

Blistex ® MEDICATED LIP BALM
LIP PROTECTANT/SUNSCREEN

SPF 15

Blistex ® MEDICATED LIP BALM
NET WT. .15 oz (4.25g)

SPF 15

Blistex ® MEDICATED LIP BALM

©2012 Blistex Inc.
P.O. Box 5392, Oak Brook, IL
60522 C36186
23012TE

DO NOT USE IF SEAL IS MISSING.

Lift for Drug Facts

Blistex

Blistex

Dimethicone, Oxybenzone, and Padimate O STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10157-9822
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 2 g
OXYBENZONE OXYBENZONE 2.5 g
PADIMATE O PADIMATE O 6.6 g

Inactive Ingredients

Ingredient Name Strength
YELLOW WAX
CETYL ALCOHOL
cetyl palmitate
CANDELILLA WAX
ISOPROPYL MYRISTATE
ISOPROPYL PALMITATE
ISOPROPYL STEARATE
LANOLIN
LANOLIN OIL
MENTHOL
METHYLPARABEN
Mineral Oil
PARAFFIN
petrolatum
POLYBUTENE (1400 MW)
PROPYLPARABEN
D&C RED NO. 6
ALUMINUM OXIDE
COCOA BUTTER
titanium dioxide

Product Characteristics

Color Shape
PINK BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10157-9822-1 4.25 in 1 CYLINDER
2 NDC:10157-9822-3 3 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2010-11-01


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