BLISTEX RASPBERRY LEMONADE BLAST- dimethicone, octinoxate, and octisalate 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 6.6%(w/w)Sunscreen
Octisalate 4.4%(w/w)Sunscreen

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

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

  • 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

Other information

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

Inactive ingredients

alumina, beeswax, caprylic/capric triglyceride, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

Blistex®
LIP PROTECTANT/SUNSCREEN

RaSPBeRRY
LemonaDe
BLaST®

Comforts & Protects
Moisturizes Dry Lips

Net Wt. 0.15 oz (4.25 g)
SPF 15

Refreshing
Fruit
Blend

Principal Display Panel - 4.25 g Cylinder Carton
BLISTEX RASPBERRY LEMONADE BLAST 
dimethicone, octinoxate, and octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1126
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) OCTINOXATE6.6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.4 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)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SACCHARIN (UNII: FST467XS7D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-1126-11 in 1 CARTON09/21/201803/10/2020
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/21/201803/10/2020
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-1126)

Revised: 3/2020
Document Id: a2e9c9c7-0e3e-48cf-ba90-38245abad36c
Set id: 77b7a641-3906-40d6-878d-748dbf28432f
Version: 2
Effective Time: 20200311
 
Blistex Inc