BLISTEX DEEP RENEWAL BROAD SPECTRUM- dimethicone, avobenzone, octinoxate, and octisalate stick

Blistex Deep Renewal Broad Spectrum by

Drug Labeling and Warnings

Blistex Deep Renewal Broad Spectrum 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
Avobenzone 3.0% (w/w)	Sunscreen
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

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
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long sleeve shirts, pants, hats, and sunglasses
• 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

atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavors, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, pentylene glycol, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

DEEP
RENEWAL®

ANTI-AGING TREATMENT

Reduces Appearance of Fine Lines

Moisturizes, Protects & Renews

coenzyme
Q∙10
with
Hyaluronic
Spheres

BROAD
SPECTRUM
SPF 15

Net Wt. 0.13 oz. (3.69 g)

INGREDIENTS AND APPEARANCE

BLISTEX DEEP RENEWAL BROAD SPECTRUM 
dimethicone, avobenzone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1108
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 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
OCTYLDODECANOL (UNII: 461N1O614Y)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
CHONDROITIN SULFATE SODIUM (SHARK) (UNII: Q75WVO004L)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN (UNII: FST467XS7D)
SORBIC ACID (UNII: X045WJ989B)
UBIDECARENONE (UNII: EJ27X76M46)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1108-1	1 in 1 BLISTER PACK	05/01/2016
1		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	05/01/2016

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-1108)