Blistex® Silk and Shine®

Blistex Silk and Shine by

Drug Labeling and Warnings

Blistex Silk and Shine by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLISTEX SILK AND SHINE- 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® Silk and Shine®

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (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

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

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, flavors, hydrogenated polyisobutene, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, saccharin, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

SILK &
SHINE®

Real Silk Extracts

Satiny Smooth Lips
Plus A Light Glossy Shine

Infused With Vitamins B5 & E

SPF 15

Net Wt. 0.13 oz. (3.69 g)

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack
BLISTEX SILK AND SHINE 
dimethicone, octinoxate, and octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10157-1125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 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
MINERAL OIL (UNII: T5L8T28FGP)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PETROLATUM (UNII: 4T6H12BN9U)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
CERESIN (UNII: Q1LS2UJO3A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PANTHENYL ETHYL ETHER (UNII: F4WMF8NX3B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SACCHARIN (UNII: FST467XS7D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10157-1125-11 in 1 BLISTER PACK05/08/201803/25/2020
13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC: 10157-1125-22 in 1 BLISTER PACK05/08/201803/25/2020
23.69 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35205/08/201803/25/2020
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-1125)

Revised: 3/2020
 
Blistex Inc.