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Name:Neutrogenapure And Free
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena Pure & Free Liquid Daily Sunblock Lotion SPF 50

NEUTROGENA PURE AND FREE - titanium dioxide and zinc oxide lotion 
Neutrogena Corporation

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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Neutrogena Pure & Free Liquid Daily Sunblock Lotion SPF 50

Directions

Shake well before use. Apply a few drops to palm and use fingertips to spread liberally over face and desired areas 15 minutes before sun exposure. Works alone or under make-up and moisturizers. For added protection, reapply as needed

Warnings

For external use only.

Not to be swallowed.

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Discontinue use if irritation or rash appear.

Use of children under 6 months of age only with advice of a physician.

Keep out of reach of children. If case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Package contains small parts, which could cause a choking hazard.

Questions or comments?

1-800-299-4786 (USA) or www.neutrogena.com

Active Ingredients

Titanium Dioxide 5 %, Zinc Oxide 3 %

Inactive Ingredients

 
Water
 
C12-15 Alkyl Benzoate
 
Trisiloxane
 
Dimethicone
 
Styrene/Acrylates Copolymer
 
Silica
 
Cetyl PEG/PPG-10/1 Dimethicone
 
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate
 
PPG-12/SMDI Copolymer
 
Bisabolol
 
Magnesium Sulfate
 
Caprylyl Glycol
 
DMDM Hydantoin
 
Triethoxycaprylylsilane
 
BHT

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label

Neutrogena®

pure & free™
liquid

daily sunblock

SPF
50

pureSCREEN™
broad spectrum uva+uvb

100% naturally
sourced sunscreens

1.4 FL OZ (40 mL)

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label

NEUTROGENA  PURE AND FREE
titanium dioxide and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-405
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 50 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 30 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
C12-15 Alkyl Benzoate  
Dimethicone  
Silicon Dioxide  
Levomenol  
Magnesium Sulfate, Unspecified  
Caprylyl Glycol  
DMDM Hydantoin  
OCTYLTRIETHOXYSILANE  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-405-01 40 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/01/2010

Labeler - Neutrogena Corporation (008254617)

Revised: 09/2010 Neutrogena Corporation



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


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