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.

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Deep Renewal

Drug Facts

Active ingredientsPurpose
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

  • 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.

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

  • protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack

NDC 10157-9835-1

Blistex®

LIP PROTECTANT/SUNSCREEN

DEEP
RENEWAL®

ANTI-AGING TREATMENT

  • Visibly Reduces Deep & Fine Lines
  • Improves Lip Health & Vitality
  • Moisturizes, Protects & Renews

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9835
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.7 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
MARINE 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
ColorWHITEScore    
ShapeSize
FlavorMINT (Citrus Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9835-11 in 1 BLISTER PACK11/01/201204/30/2016
13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/01/201204/30/2016
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-9835)

Revised: 4/2016
Document Id: 1e12657d-e0a1-4a12-b419-d324bd4cbf50
Set id: cd0f8487-0fc5-4fda-8bfe-b33057bbe3e3
Version: 2
Effective Time: 20160406
 
Blistex Inc