Drug Facts

Active ingredients	Purpose
Avobenzone 3.0% (w/w)	Sunscreen
Dimethicone 2.0% (w/w)	Lip protectant
Homosalate 9.0% (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, 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

DEEP
RENEWAL®

FOR YOUNGER LOOKING LIPS

Smooths & Softens Lips

Moisturizes, Protects
& Revitalizes

ENHANCEMENT SERIES®

coenzyme
Q∙10

with
Hyaluronic
Spheres

BROAD
SPECTRUM
SPF 15

Net Wt. 0.13 oz. (3.69 g)

Principal Display Panel - 3.69 g Cylinder Blister Pack

DEEP RENEWAL BROAD SPECTRUM
dimethicone, avobenzone, homosalate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-1170
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
OCTYLDODECANOL (UNII: 461N1O614Y)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SACCHARIN (UNII: FST467XS7D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
UBIDECARENONE (UNII: EJ27X76M46)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10157-1170-1	1 in 1 BLISTER PACK	09/09/2020
1		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC:10157-1170-2	2 in 1 BLISTER PACK	09/09/2020
2		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	09/09/2020

Labeler - Blistex Inc (005126354)