BLISTEX  ORANGE MANGO BLAST- dimethicone, octinoxate, and oxybenzone 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®
Orange Mango Blast™

Drug Facts

Active ingredientsPurpose
Dimethicone 1.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

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

PACKAGE WARNING

CHOKING HAZARD. Has removable cap. Not for children under 3 years.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

alumina, beeswax, citrus nobilis (mandarin orange) fruit extract, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, isopropyl palmitate, isopropyl stearate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyethylene, polyhydroxystearic acid, saccharin, silica, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

NDC 10157-8008-1

BLISTEX®
LIP PROTECTANT/SUNSCREEN

ORANGE
MANGO
BLAST

New!

Comforts & Protects
Moisturizes Dry Lips

NET WT. .15 oz (4.25g)

SPF 15

Principal Display Panel - 4.25 g Cylinder Carton
BLISTEX   ORANGE MANGO BLAST
dimethicone, octinoxate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Microcrystalline Wax (UNII: XOF597Q3KY)  
Hydrogenated Coconut Oil (UNII: JY81OXM1OM)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
Diethylhexyl Adipate (UNII: MBY1SL921L)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Isopropyl Stearate (UNII: 43253ZW1MZ)  
Tangerine (UNII: KH3E3096OO)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Myristyl Myristate (UNII: 4042ZC00DY)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Aluminum Oxide (UNII: LMI26O6933)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Saccharin (UNII: FST467XS7D)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
High Density Polyethylene (UNII: UG00KM4WR7)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-8008-11 in 1 CARTON
14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34702/14/2014
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-8008)

Revised: 1/2014
Document Id: c4e81536-9e92-48cf-9e69-8cdf57ec2b37
Set id: 477b6402-5529-48fe-9108-ba74c118aeba
Version: 1
Effective Time: 20140102
 
Blistex Inc.