Neutrogena Pure and Free Baby Faces Ultra Gentle Sunscreen Broad Spectrum SPF45 Plus

Dosage form: lotion
Ingredients: Titanium Dioxide 51mg in 1mL, Zinc Oxide 29mg in 1mL
Labeler: Neutrogena Corporation
NDC Code: 10812-420

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.

Pure & Free Baby Faces Ultra Gentle Sunscreen
Broad Spectrum SPF 45+

Drug Facts

Active ingredients

Titanium Dioxide 5.1%
Zinc Oxide 2.9%

Purpose

Sunscreen

Uses
  • Helps prevent sunburn
  • (Optional) If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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 generously 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeved shirts, pants hats, and sunglasses
  • Children under 6 months: Ask a doctor

Other information
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Inactive Ingredients

Aluminum Hydroxide, C12-15 Alkyl Benzoate, Carbomer, Cetyl Alcohol, Cetyl Dimethicone, Cetyl Hydroxyethylcellulose, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer , Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium Phosphate, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Hydrated Silica, Isopropyl Myristate, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-4 Isostearate, Silica, Sodium Hydroxide, Sodium Phosphate, Stearic Acid, Styrene/Acrylates Copolymer, riethoxycaprylylsilane, Trisiloxane, Water

Questions or comments?

Visit www.neutrogena.com or call toll-free 800-299-4786 or 215-273-8755 (collect)

Dist. by Neutrogena Corporation Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 73 mL Tube Carton

Neutrogena®

pure & free®
baby faces
ultra gentle cream

SUNSCREEN
Broad Spectrum
SPF 45+

pureSCREEN®
broad spectrum uva-uvb

TEAR FREE
100% naturally sourced sunscreens
hypoallergenic
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

2.5 FL OZ (73mL)

NEUTROGENA PURE AND FREE BABY FACES   ULTRA GENTLE SUNSCREEN BROAD SPECTRUM SPF45 PLUS
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-420
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide51 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide29 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aluminum Hydroxide 
Alkyl (C12-15) Benzoate 
Cetyl Alcohol 
Dimethicone 
Sodium Phosphate, Dibasic, Anhydrous 
Ethylhexylglycerin 
Glycerin 
Hexyl Laurate 
Hydrated Silica 
Isopropyl Myristate 
Magnesium Sulfate 
Phenoxyethanol 
Polyglyceryl-4 Isostearate 
Silicon Dioxide 
Sodium Hydroxide 
sodium Phosphate 
Stearic Acid 
Triethoxycaprylylsilane 
Trisiloxane 
Water 
Packaging
#Item CodePackage Description
1NDC:10812-420-011 TUBE in 1 CARTON
173 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/13/2012
Labeler - Neutrogena Corporation (008254617)

Revised: 06/2012
 
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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