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Name:Neutrogena Ultra Sheer Dry Touch Sunblock Spf 45 With Helioplex
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena Ultra Sheer Dry-Touch Sunblock SPF 45

NEUTROGENA ULTRA SHEER DRY TOUCH SUNBLOCK  SPF 45 WITH HELIOPLEX - avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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 Ultra Sheer Dry-Touch Sunblock SPF 45

Directions

Apply liberally and evenly to all exposed areas 15-30 minutes before sun exposure. For added protection, reapply after swimming, towel drying, or extended sun exposure.

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 this and all drugs out of the reach of children. If case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Questions or comments?

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

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Inactive Ingredients

Water
Silica
Styrene/Acrylates Copolymer
Potassium Cetyl Phosphate
Beeswax
Benzyl Alcohol
Glyceryl Stearate
PEG-100 Stearate
Cetyl Dimethicone
Dimethicone
Caprylyl Methicone
Caprylyl Glycol
Ethylhexylglycerin
Behenyl Alcohol
Sodium Polyacrylate
Xanthan Gum
Dimethicone/PEG-10/15 Crosspolymer
Ethylhexyl Stearate
Acrylates/C12-22 Alkyl Methacrylate Copolymer
Disodium EDTA
Chlorphenesin
Fragrance
Diethylhexyl 2,6-Naphthalate
BHT
Trideceth-6

© Dist. by Neutrogena Corp., Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Neutrogena®

Ultra Sheer

DRY-TOUCH
SUNBLOCK

SPF
45

helioplex®
broad spectrum uva-uvb

LIGHTWEIGHT
CLEAN FEEL

fast absorbing
leaves skin soft and smooth
waterproof

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL OZ (88 mL)

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

NEUTROGENA ULTRA SHEER DRY TOUCH SUNBLOCK   SPF 45 WITH HELIOPLEX
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-507
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 30 mg  in 1 mL
Homosalate (Homosalate) Homosalate 100 mg  in 1 mL
Octisalate (Octisalate) Octisalate 50 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene 40 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Silicon Dioxide  
Potassium Cetyl Phosphate  
Yellow Wax  
Benzyl Alcohol  
Glyceryl Monostearate  
PEG-100 Stearate  
Dimethicone  
Caprylyl Glycol  
Ethylhexylglycerin  
Docosanol  
Xanthan Gum  
Edetate Disodium  
Chlorphenesin  
Diethylhexyl 2,6-Naphthalate  
Butylated Hydroxytoluene  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-507-01 88 mL in 1 TUBE None
2 NDC:10812-507-02 12 TUBE ( TUBE) in 1 TRAY contains a TUBE
2 14 mL in 1 TUBE This package is contained within the TRAY (10812-507-02)
3 NDC:10812-507-03 2 TUBE ( TUBE) in 1 PACKAGE contains a TUBE
3 88 mL in 1 TUBE This package is contained within the PACKAGE (10812-507-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/02/2011

Labeler - Neutrogena Corporation (008254617)

Revised: 06/2011 Neutrogena Corporation



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


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