Your browser does not support JavaScript! BLISTEX COMPLETE MOISTURE (OCTINOXATE, OXYBENZONE, AND DIMETHICONE) STICK [BLISTEX INC.]
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BLISTEX COMPLETE MOISTURE (octinoxate, oxybenzone, and dimethicone) stick
[Blistex Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0%(w/w)Lip protectant
Octinoxate 7.5%(w/w)Sunscreen
Oxybenzone 2.5%(w/w)Sunscreen

Uses

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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
  • children under 6 months of age: Ask a doctor

Inactive ingredients

behenoyl stearic acid, butylparaben, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, ethylparaben, flavor, glycerin, jojoba esters, lecithin, methylparaben, microcrystalline wax, ozokerite, panthenol, petrolatum, propylparaben, purified water, sodium borate, sodium saccharin, squalane

Other information

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

PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton

NDC 10157-9877-1

Blistex®
LIP PROTECTANT/SUNSCREEN

COMPLETE
MOISTURE®

Moisture Plus
Ultra-Hydrating Ingredients

Penetrates To Quench Dry Lips

NET WT. .15 oz (4.25g)

SPF 15

PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton
BLISTEX   COMPLETE MOISTURE
octinoxate, oxybenzone, and dimethicone stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10157-9877
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Dimethicone (Dimethicone) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL ADIPATE 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
METHYLPARABEN 
water 
saccharin sodium 
squalane 
panthenol 
microcrystalline wax 
glycerin 
ETHYLHEXYL STEARATE 
ETHYLHEXYL PALMITATE 
MEDIUM-CHAIN TRIGLYCERIDES 
petrolatum 
7-BEHENOYLSTEARIC ACID 
SODIUM BORATE 
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE 
ceresin 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9877-11 in 1 CARTON
14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34703/05/2003
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9877)

Revised: 11/2013
 
Blistex Inc.

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