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Name:Blistexlip Massage
Manufacturer:Blistex Inc
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

BLISTEX LIP MASSAGE - petrolatum, octinoxate, avobenzone, octocrylene and oxybenzone gel 
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


Avobenzone 3.0%

Octinoxate 7.5%

Octocrylene 2.7%

Oxybenzone 2.5%

Petrolatum 42.33





SKIN PROTECTANT

SUNSCREEN



  • Temporarily protects and helps relieve chapped or cracked lips
  • Helps protect lips from the drying effects of wind  and cold weather
  • Helps prevent sunburn




  • Apply liberally before sun exposure and as needed
  • First use may take up to ten turns to dispense, subsequent uses should require only one turn

  • Do not use on deep or puncture wounds
  • animal bites
  • serious burns
  • Stop use if skin rash occurs
  • Children under six months of age ask a doctor


Blistex Lip Massage


Lip Protector/ Sunscreen


Smooths away Rough Spots

Soft formula invigorates, protects and moisturizers

SPF15


Lip Massage



BLISTEX  LIP MASSAGE
blistex lip massage gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9875
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 43.33 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2.7 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 2.5 g
Product Characteristics
Color      Score     
Shape Size
Flavor BLACKBERRY (Blackberry) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10157-9875-1 1 GEL ( TUBE) in 1 TUBE, WITH APPLICATOR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/15/2009

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

Revised: 12/2009 Blistex Inc



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


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