Neutrogena Ultra Sheer Dry Touch Sunblock SPF 30 Helioplex

Dosage form: lotion
Ingredients: Avobenzone 30mg in 1mL, Homosalate 80mg in 1mL, Octisalate 50mg in 1mL, Octocrylene 40mg in 1mL, Oxybenzone 40mg in 1mL
Labeler: Neutrogena Corporation
NDC Code: 10812-372

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 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)

NEUTROGENA ULTRA SHEER DRY TOUCH SUNBLOCK   SPF 30 HELIOPLEX
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-372
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30 mg  in 1 mL
Homosalate (Homosalate) Homosalate80 mg  in 1 mL
Octisalate (Octisalate) Octisalate50 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene40 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:10812-372-0188 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/15/201109/20/2016
Labeler - Neutrogena Corporation (008254617)

Revised: 09/2012
 
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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