BLISTEX  RASPBERRY LEMONADE 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®
Raspberry Lemonade 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

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

Directions

Inactive ingredients

alumina, beeswax, 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

Other information

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Label

Blistex®

SPF 15

RaSPBeRRY
LemonaDe BLaST
®

NET WT. .15 oz (4.25g)

Principal Display Panel - 4.25 g Cylinder Label
BLISTEX   RASPBERRY LEMONADE BLAST
dimethicone, octinoxate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9800
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
aluminum oxide (UNII: LMI26O6933)  
yellow wax (UNII: 2ZA36H0S2V)  
diethylhexyl adipate (UNII: MBY1SL921L)  
ethylhexyl palmitate (UNII: 2865993309)  
ethylhexyl stearate (UNII: EG3PA2K3K5)  
glyceryl monostearate (UNII: 230OU9XXE4)  
hydrogenated coconut oil (UNII: JY81OXM1OM)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
isopropyl stearate (UNII: 43253ZW1MZ)  
microcrystalline wax (UNII: XOF597Q3KY)  
myristyl myristate (UNII: 4042ZC00DY)  
phenoxyethanol (UNII: HIE492ZZ3T)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
high density polyethylene (UNII: UG00KM4WR7)  
saccharin (UNII: FST467XS7D)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
titanium dioxide (UNII: 15FIX9V2JP)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
Product Characteristics
ColorWHITEScore    
ShapeBULLETSize
FlavorRASPBERRY (lemonade) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9800-14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/01/2010
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-9800)

Revised: 3/2013
Document Id: dc72ce14-fe53-427a-b293-de9e03c20501
Set id: 871156e9-2110-4c8e-bf4f-0ef84fcd3aa7
Version: 1
Effective Time: 20130312
 
Blistex Inc