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Name:Neutrogena Ultra Sheer Dry Touch Sunblock Spf 30 Helioplex
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena Ultra Sheer Dry-Touch Sunblock SPF 30

NEUTROGENA ULTRA SHEER DRY TOUCH SUNBLOCK  SPF 30 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 30

Directions

Apply liberally on face and body 15 minutes before sun exposure. For added protection, reapply after swimming, excessing sweating, towel drying or extended sun exposure.

Active Ingredients

Avobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 4%, Oxybenzone 4%

Warnings

For external use only.

Not to be swallowed. Avoid contact with eyes.

Discontinue use if irritation or rash appear.

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

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

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Neutrogena®

Ultra Sheer
DRY-TOUCH
SUNBLOCK

SPF
30
helioplex®
broad spectrum uva-uvb

LIGHTWEIGHT
CLEAN FEEL

fast absorbing
leaves skin soft and smooth
waterproof

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL OZ (88mL)

Principal Display Panel - 88 mL Tube Label

NEUTROGENA ULTRA SHEER DRY TOUCH SUNBLOCK   SPF 30 HELIOPLEX
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-372
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 80 mg  in 1 mL
Octisalate (Octisalate) Octisalate 50 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene 40 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone 40 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Silicon Dioxide  
Dimethicone  
Potassium Cetyl Phosphate  
Yellow Wax  
Benzyl Alcohol  
Glyceryl Monostearate  
PEG-100 Stearate  
Caprylyl Glycol  
Ethylhexylglycerin  
Docosanol  
Xanthan Gum  
Ethylhexyl Stearate  
Edetate Disodium  
Chlorphenesin  
Diethylhexyl 2,6-Naphthalate  
Butylated Hydroxytoluene  
Trideceth-6  
Propylene Glycol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-372-01 88 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/15/2011

Labeler - Neutrogena Corporation (008254617)

Revised: 03/2011 Neutrogena Corporation



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


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