DEEP RENEWAL- avobenzone, octinoxate, octocrylene, oxybenzone and dimethicone stick 
Blistex Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Deep Renewal

Drug Facts

Active ingredients Purpose
Avobenzone 3.0% (w/w) Sunscreen
Dimethicone 2.0% (w/w) Lip protectant
Octinoxate 7.5% (w/w) Sunscreen
Octocrylene 2.7% (w/w) Sunscreen
Oxybenzone 2.5% (w/w) Sunscreen

Uses

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

Inactive ingredients

atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavor, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, petrolatum, phenoxyethanol, polybutene, polyethylene, PTFE, 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 - 3.69g Cylinder Blister Pack

NDC 10157-9835-1

Blistex®

LIP PROTECTANT/SUNSCREEN

DEEP
RENEWAL®

ANTI-AGING TREATMENT

coenzyme
Q•10

with
Hyaluronic
Spheres

BROAD
SPECTRUM
SPF 15

NET WT. .13 oz (3.69g)

PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack
DEEP RENEWAL 
avobenzone, octinoxate, octocrylene, oxybenzone, and dimethicone stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9835
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.7 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.5 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 2 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
yellow wax (UNII: 2ZA36H0S2V)  
butylene glycol (UNII: 3XUS85K0RA)  
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)  
ethylhexyl palmitate (UNII: 2865993309)  
lanolin alcohols (UNII: 884C3FA9HE)  
microcrystalline wax (UNII: XOF597Q3KY)  
octyldodecanol (UNII: 461N1O614Y)  
pentaerythrityl tetraisostearate (UNII: 9D7IK5483F)  
petrolatum (UNII: 4T6H12BN9U)  
phenoxyethanol (UNII: HIE492ZZ3T)  
high density polyethylene (UNII: UG00KM4WR7)  
polytetrafluoroethylene (UNII: E1NC1JVS3O)  
castor oil (UNII: D5340Y2I9G)  
saccharin (UNII: FST467XS7D)  
silica dimethyl silylate (UNII: EU2PSP0G0W)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
sorbic acid (UNII: X045WJ989B)  
squalane (UNII: GW89575KF9)  
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
Polybutene (1400 MW) (UNII: 1NA5AO9GH7)  
FISH SKIN COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
CHONDROITIN SULFATE SODIUM (SHARK) (UNII: Q75WVO004L)  
UBIDECARENONE (UNII: EJ27X76M46)  
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor MINT (Citrus Mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10157-9835-1 1 in 1 BLISTER PACK
1 3.69 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 11/01/2012
Labeler - Blistex Inc (005126354)
Establishment
Name Address ID/FEI Business Operations
Blistex Inc 005126354 MANUFACTURE(10157-9835)

Revised: 10/2012
Document Id: ef7cf65e-848d-48bc-b2be-bc4a10715760
Set id: cd0f8487-0fc5-4fda-8bfe-b33057bbe3e3
Version: 1
Effective Time: 20121031
 
Blistex Inc