Neutrogena Pure and Free

Dosage form: lotion
Ingredients: Titanium Dioxide 50mg in 1mL, Zinc Oxide 30mg in 1mL
Labeler: Neutrogena Corporation
NDC Code: 10812-405

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.

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)

NEUTROGENA  PURE AND FREE
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-405
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide50 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alkyl (C12-15) Benzoate 
Dimethicone 
Silicon Dioxide 
Levomenol 
Magnesium Sulfate 
Caprylyl Glycol 
DMDM Hydantoin 
Triethoxycaprylylsilane 
Butylated Hydroxytoluene 
Packaging
#Item CodePackage Description
1NDC:10812-405-0140 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/201010/16/2015
Labeler - Neutrogena Corporation (008254617)

Revised: 10/2012
 
Neutrogena Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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