SILK AND SHINE- dimethicone, octinoxate, and oxybenzone stick

Silk and Shine by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Dimethicone 2.0% (w/w)	Lip protectant
Octinoxate 7.5% (w/w)	Sunscreen
Oxybenzone 2.5% (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

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

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

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)

INGREDIENTS AND APPEARANCE

SILK AND SHINE 
dimethicone, octinoxate, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9882
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9882-1	1 in 1 BLISTER PACK
1		3.69 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	11/01/2012

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-9882)