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Blistex

Blistex Inc.

Blistex Ultra-Rich Hydration


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Dimethicone 2.0% (w/w) Lip protectant
Octinoxate 6.8% (w/w) Sunscreen
Oxybenzone 3.0% (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

Blistex Other information

  • protect the product from excessive heat and direct sun

Inactive ingredients

aloe barbadensis leaf extract, alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea butter), ceresin, cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, isostearoyl hydrolyzed silk, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, theobroma cacao (cocoa) seed butter, titanium dioxide, tocopheryl acetate, triticum vulgare (wheat) germ oil

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

NDC 10157-8015-1
Blistex ®
LIP PROTECTANT/SUNSCREEN

ULTRA-RICH
HYDRATION

NEW!

Dual-Layer Balm

INNER: Deeply Hydrates With
80% Moisturizers

OUTER: Smoothes & Seals
With Lush Protectants

SPF 15

NET WT. .13 oz (3.69g)

Blistex

Blistex

Octinoxate, Oxybenzone, and Dimethicone STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10157-8015
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 6.8 g
OXYBENZONE OXYBENZONE 3 g
DIMETHICONE 2 g

Inactive Ingredients

Ingredient Name Strength
YELLOW WAX
PENTAERYTHRITYL TETRAETHYLHEXANOATE
petrolatum
PARAFFIN
HYDROGENATED CASTOR OIL
MICROCRYSTALLINE WAX
ISOPROPYL MYRISTATE
titanium dioxide
SHEA BUTTER
ALUMINUM OXIDE
SILICON DIOXIDE
cetyl palmitate
ARACHIDYL ALCOHOL
docosanol
ARACHIDYL GLUCOSIDE
olive oil
Aloe Vera Leaf
.ALPHA.-TOCOPHEROL ACETATE
WHEAT GERM OIL
PHENYL TRIMETHICONE
SUNFLOWER OIL
CHAMOMILE
Ceresin
COCOA BUTTER
SACCHARIN
FD&C BLUE NO. 1
PHENOXYETHANOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 3.69 in 1 CYLINDER
2 NDC:10157-8015-1 1 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2014-05-30


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