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Name:Neutrogena Ultra Gentle Soothing Spf15
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena Ultra Gentle Soothing Lotion SPF 15

NEUTROGENA ULTRA GENTLE SOOTHING  SPF15 - avobenzone, octinoxate and octisalate 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 Gentle Soothing Lotion SPF 15

Directions

Apply daily on clean skin. Massage evenly over face and neck. Can be used under make-up.

Active Ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

Inactive Ingredients

Water
C12-15 Alkyl Benzoate
Cetearyl Alcohol
Dimethicone
Trisiloxane
Glycerin
Arachidyl Alcohol
Phenyl Trimethicone
Cetearyl Glucoside
Phenoxyethanol
Ethylene/Acrylic Acid Copolymer
Benzyl Alcohol
Propylene Glycol
Behenyl Alcohol
Steareth-2
Sodium Cocoyl Amino Acids
Butylene Glycol
Fragrance
Steareth-21
Polyacrylamide
Arachidyl Glucoside
Disodium EDTA
Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice
Chlorphenesin
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Propylparaben
C13-14 Isoparaffin
Ethylparaben
Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate
Sarcosine
Laureth-7
Artemisia Abrotanum Flower/Leaf/Stem Extract
Sodium Hydroxide
Chamomilla Recutita (Matricaria) Flower Extract
Potassium Aspartate
Magnesium Aspartate
Codium Tomentosum Extract

Warnings

For external use only. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Discontinue use if irritation or rash appear.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NEW

ultra gentle
soothing
lotion

SPF 15
UVA/UVB protection

Clinically proven to
instantly soothe even
the most sensitive skin

Visibly reduce redness

Neutrogena®

DERMATOLOGIST RECOMMENDED

4.0 FL OZ (118 mL)

Principal Display Panel - 118 mL Bottle Carton

NEUTROGENA ULTRA GENTLE SOOTHING   SPF15
avobenzone, octinoxate, and octisalate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-378
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 30 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate 75 mg  in 1 mL
Octisalate (Octisalate) Octisalate 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Alkyl (C12-15) Benzoate  
Cetostearyl Alcohol  
Dimethicone  
Trisiloxane  
Glycerin  
Arachidyl Alcohol  
Phenyl Trimethicone  
Cetearyl Glucoside  
Phenoxyethanol  
Benzyl Alcohol  
Propylene Glycol  
Docosanol  
Steareth-2  
Butylene Glycol  
Steareth-21  
Arachidyl Glucoside  
Edetate Disodium  
Chlorphenesin  
Propylparaben  
C13-14 Isoparaffin  
Ethylparaben  
Sarcosine  
Laureth-7  
Artemisia Abrotanum Flowering Top  
Sodium Hydroxide  
Chamomile  
Potassium Aspartate  
Magnesium Aspartate  
Codium Tomentosum  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-378-01 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 118 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (10812-378-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/01/2011

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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