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Name:Neutrogena Ultra Sheer Dry Touch Sunblock Spf 100 Plus
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Ultra Sheer SPF 100

NEUTROGENA ULTRA SHEER DRY TOUCH SUNBLOCK  SPF 100 PLUS - 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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Ultra Sheer SPF 100

Directions

For best results, use daily. Apply liberally on face 15 minutes before sun exposure. For added protection, reapply after swimming, towel drying, excessive perspiration or extended sun exposure.

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Inactive Ingredients

Water
Styrene/Acrylates Copolymer
Silica
Beeswax
Cyclopentasiloxane
Ethylhexylglycerin
Glyceryl Stearate
PEG-100 Stearate
Acrylates/Dimethicone Copolymer
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Chlorphenesin
Disodium EDTA
Triethanolamine
Dipotassium Glycyrrhizate
BHT
Methylisothiazolinone
Diethylhexyl 2,6-Naphthalate
Fragrance

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.

PRINCIPAL DISPLAY PANEL - 88 mL Label

NEW

Neutrogena®

Ultra Sheer

DRY-TOUCH
SUNBLOCK

SPF
100+

with
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 Label

NEUTROGENA ULTRA SHEER DRY TOUCH SUNBLOCK   SPF 100 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-366
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 150 mg  in 1 mL
Octisalate (Octisalate) Octisalate 50 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene 100 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone 60 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-366-01 88 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/01/2010

Labeler - Neutrogena Corporation (008254617)

Revised: 04/2010 Neutrogena Corporation



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


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