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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10157-9835
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone3 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Octocrylene (Octocrylene) Octocrylene2.7 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Dimethicone (Dimethicone) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
yellow wax 
butylene glycol 
dipalmitoyl hydroxyproline 
ethylhexyl palmitate 
lanolin alcohols 
microcrystalline wax 
octyldodecanol 
pentaerythrityl tetraisostearate 
petrolatum 
phenoxyethanol 
high density polyethylene 
polytetrafluoroethylene 
castor oil 
saccharin 
silica dimethyl silylate 
hyaluronate sodium 
sorbic acid 
squalane 
tetrahexyldecyl ascorbate 
Polybutene (1400 MW) 
FISH SKIN COLLAGEN, SOLUBLE 
CHONDROITIN SULFATE SODIUM (SHARK) 
UBIDECARENONE 
SIMMONDSIA CHINENSIS SEED WAX 
.alpha.-tocopherol acetate 
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 PACK
13.69 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/01/2012
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(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