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Name:Neutrogena Pure And Free Baby Sunblockspf 60plus Purescreen
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena Pure & Free Baby Sunblock Lotion SPF 60+

NEUTROGENA PURE AND FREE BABY SUNBLOCK SPF 60PLUS PURESCREEN - titanium dioxide and zinc oxide 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 Pure & Free Baby Sunblock Lotion SPF 60+

Directions

Ask doctor before use on children under 6 months of age. Apply liberally and evenly before sun exposure. Ensure complete coverage. Reapply as needed or after swimming, perspiring, towel drying, or vigorous activity.

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. Package contains small parts, which could cause a choking hazard.

Questions or comments?

1-800-299-4786 (USA)

Active Ingredients

Titanium Dioxide 4.9%, Zinc Oxide 4.7%

Inactive Ingredients

Alumina
Arachidyl Alcohol
Arachidyl Glucoside
Ascorbic Acid
Avena Sativa (Oat) Kernel Extract
Beeswax
Behenyl Alcohol
Benzyl Alcohol
BHT
Bisabolol
Butylene Glycol
Butyloctyl Salicylate
Cetyl Dimethicone
Dimethicone
Dimethicone PEG-8 Laurate
Dipotassium Glycyrrhizate
Disodium EDTA
Ethylhexylglycerin
Glycerin
Glyceryl Stearate
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer
Isohexadecane
Methicone
Methylisothiazolinone
Pantothenic Acid
PEG-100 Stearate
PEG-8
Polyaminopropyl Biguanide
Polyhydroxystearic Acid
Polymethyl Methacrylate
Polysorbate 60
Potassium Sorbate
Retinyl Palmitate
Silica
Stearic Acid
Styrene/Acrylates Copolymer
Tocopheryl Acetate
Triethoxycaprylylsilane
Trimethylsiloxysilicate
Trisiloxane
Water
Xanthan Gum

PRINCIPAL DISPLAY PANEL - 147 mL Tube Label

VALUE SIZE
Neutrogena®
pure & free®
baby
sunblock lotion

SPF
60+
pure
screen®
broad spectrum uva•uvb

naturally sourced
sunscreen ingredients

won't run into eyes and sting
waterproof

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

5.0 FL OZ (147 mL)

Principal Display Panel - 147 mL Tube Label

NEUTROGENA PURE AND FREE BABY SUNBLOCK  SPF 60PLUS PURESCREEN
titanium dioxide and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-322
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 49 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 47 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Aluminum Oxide  
Arachidyl Alcohol  
Ascorbic Acid  
Oat  
Yellow Wax  
Docosanol  
Benzyl Alcohol  
Butylated Hydroxytoluene  
Levomenol  
Butylene Glycol  
Edetate Disodium  
Ethylhexylglycerin  
Glycerin  
Glyceryl Monostearate  
Isohexadecane  
Methylisothiazolinone  
Polyoxyl 100 Stearate  
Polyethylene Glycol 400  
Polyaminopropyl Biguanide  
Polysorbate 60  
Potassium Sorbate  
Vitamin A Palmitate  
Silicon Dioxide  
Stearic Acid  
.Alpha.-Tocopherol Acetate, D-  
Trisiloxane  
Water  
Xanthan Gum  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-322-02 147 mL in 1 TUBE None
2 NDC:10812-322-01 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 12/01/2010

Labeler - Neutrogena Corporation (008254617)

Revised: 10/2010 Neutrogena Corporation



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


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