BLISTEX TRIPLE ESSENTIALS- octinoxate, octisalate, and dimethicone stick

Blistex Triple Essentials by

Drug Labeling and Warnings

Blistex Triple Essentials 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 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

anthemis nobilis (chamomile) flower oil, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, citrus aurantium dulcis (orange) fruit extract, citrus nobilis (mandarin orange) peel oil, cymbopogon martini (palmarosa) oil, flavors, hydrogenated polyisobutene, microcrystalline wax, mineral oil, ozokerite, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, saccharin, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

New!

ENHANCEMENT SERIES®

TRIPLE
ESSENTIALS™

3 Essential Oils

Mandarin, Palmarosa
& Chamomile

Moisturizes & Comforts
Without An Oily Feel

SPF 15

Net Wt. 0.13 oz. (3.69 g)

INGREDIENTS AND APPEARANCE

BLISTEX TRIPLE ESSENTIALS 
octinoxate, octisalate, and dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6.6 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4.4 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ORANGE (UNII: 5EVU04N5QU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1118-1	1 in 1 BLISTER PACK	07/01/2017
1		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1118-2	2 in 1 BLISTER PACK	07/01/2017
2		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	07/01/2017

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-1118)