BLISTEX SUPERFRUIT SOOTHER- dimethicone, octinoxate, and octisalate stick

Blistex Superfruit Soother by

Drug Labeling and Warnings

Blistex Superfruit Soother 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

beeswax, caprylic/capric triglyceride, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, euterpe oleracea (acai) fruit extract, flavor, isopropyl myristate, lanolin, lanolin oil, menthoxypropanediol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, rubus chamaemorus (cloudberry) fruit extract, saccharin, tetrahexyldecyl ascorbate, theobroma cacao (cocoa) seed butter, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

Blistex®
LIP PROTECTANT/SUNSCREEN

NEW!

Superfruit
Soother®

Protects & Revives
With Antioxidants & Vitamins

Cloudberry & Acai
Plus A Touch Of Cooling Mint

Net Wt. 0.15 oz. (4.25 g)

SPF 15

Superfruit
Infusion
For Lips

INGREDIENTS AND APPEARANCE

BLISTEX SUPERFRUIT SOOTHER 
dimethicone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1135
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	6.6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN OIL (UNII: OVV5IIJ58F)
YELLOW WAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CANDELILLA WAX (UNII: WL0328HX19)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETYL ALCOHOL (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ACAI (UNII: 46AM2VJ0AW)
RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
SACCHARIN (UNII: FST467XS7D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1135-1	1 in 1 CARTON	05/29/2018
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1135-2	2 in 1 CARTON	05/29/2018
2		4.25 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	05/29/2018

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-1135)