BLISTEX ORANGE MANGO BLAST- dimethicone, octinoxate, and octisalate stick

Blistex Orange Mango Blast by

Drug Labeling and Warnings

Blistex Orange Mango Blast 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 1.0% (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

PACKAGE WARNING

CHOKING HAZARD. Has removable cap. Not for children under 3 years.

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

alumina, beeswax, caprylic/capric triglyceride, citrus nobilis (mandarin orange) fruit extract, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

Blistex®
LIP PROTECTANT/SUNSCREEN

ORaNGe
MaNGO
BLaST®

Comforts & Protects
Moisturizes Dry Lips

Net Wt. 0.15 oz. (4.25 g)

SPF 15

Refreshing
Flavor
Blend

INGREDIENTS AND APPEARANCE

BLISTEX ORANGE MANGO BLAST 
dimethicone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1147
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 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
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SACCHARIN (UNII: FST467XS7D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1147-1	1 in 1 CARTON	09/07/2018
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1147-4	4 in 1 CARTON	09/07/2018
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	09/07/2018

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-1147)