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Name:Blistex Five Star
Manufacturer:Blistex Inc
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

BLISTEX  FIVE STAR - petrolatum , homosalate, octisalate, octinoxate and oxybenzone 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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DRUG FACTS

Petrolatum

Hemosalate

Octinoxate

Oxybenzone

Octisalate

SKIN PROTECTANT/ SUNSCREEN

  • Temporarily protects and helps relieve chapped or cracked lips

  • Helps protect lips from the drying effects of wind, cold weather
  • Helps prevent sunburn

FOR EXTERNAL USE ONLY


  • Do not use on * deep puncture wounds* animal bites* serious burns
  • Stop use if skin rash occurs
  • Adults and children 2 years of age and older: apply liberally to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age : consult a doctor.




BLISTEX

FIVE STAR
LIP PROTECTION


  • Holds in moisture in Dry air
  • Soothes cold chapped lips
  • Rehydrates heat stressed lips
  • Forms a wind resistant  moisture shield
  • UVA/UVB sun protection

NET WT. .15oz. (4.25g)   SPF





Blistex Five Star Lip Protection







BLISTEX   FIVE STAR
lip protection stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9825
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM ) PETROLATUM 30.1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 9.6 g
OCTISALATE (OCTISALATE) OCTISALATE 5.0 g
OCTINOXATE (OCTINOXATE ) OCTINOXATE 7.5 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 5.0 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10157-9825-1 1 STICK ( STICK) in 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/01/2010

Labeler - Blistex Inc (005126354)
Establishment
Name Address ID/FEI Operations
Blistex Inc 005126354 manufacture

Revised: 01/2010 Blistex Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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