SILK AND SHINE- 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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Silk & Shine

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (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

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, PPG-5-Ceteth-20, saccharin, titanium dioxide, tocopheryl acetate

Other information

PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack

NDC 10157-9882-1
Blistex®
LIP PROTECTANT/SUNSCREEN

SILK &
SHINE®

Now!
More Silk
More Shine

Satiny Smooth Lips
Plus A Light Glossy Shine
SPF 15

Infused With Real Silk Extracts

NET WT. .13 oz (3.69g)

PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack
SILK AND SHINE 
dimethicone, octinoxate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9882
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) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
arachidyl alcohol (UNII: 1QR1QRA9BU)  
arachidyl glucoside (UNII: 6JVW35JOOJ)  
docosanol (UNII: 9G1OE216XY)  
mica (UNII: V8A1AW0880)  
microcrystalline wax (UNII: XOF597Q3KY)  
mineral oil (UNII: T5L8T28FGP)  
panthenyl ethyl ether (UNII: F4WMF8NX3B)  
paraffin (UNII: I9O0E3H2ZE)  
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
petrolatum (UNII: 4T6H12BN9U)  
phenoxyethanol (UNII: HIE492ZZ3T)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
saccharin (UNII: FST467XS7D)  
titanium dioxide (UNII: 15FIX9V2JP)  
isopropyl behenate (UNII: 1BWO0L9BHI)  
Ceresin (UNII: Q1LS2UJO3A)  
Polybutene (1400 MW) (UNII: 1NA5AO9GH7)  
Silk, Acid Hydrolyzed (1000 MW) (UNII: 8549W658QV)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9882-11 in 1 BLISTER PACK
13.69 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/01/2012
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-9882)

Revised: 10/2012
Document Id: 9b06adb6-9147-4183-ae9b-93c1cfb81179
Set id: 24d00bd0-446e-4412-a5a3-03d5e027fa6f
Version: 1
Effective Time: 20121017
 
Blistex Inc