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Name:Neutrogena Spectrum Plus Advanced Sunblock Spf 100 Plus Helioplex 360
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena Spectrum+ Advanced Sunblock Spray SPF 100+

NEUTROGENA SPECTRUM PLUS ADVANCED SUNBLOCK  SPF 100 PLUS HELIOPLEX 360 - avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray 
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 Spectrum+ Advanced Sunblock Spray SPF 100+

Directions

Apply 15-30 minutes before sun exposure. Hold Can 4-6 inches away from body. To ensure complete coverage, spray continuously and evenly, taking time to cover all exposed areas. Do not spray in wind. Do not spray into face. Spray into hand and apply to the face. Use in well ventilated areas. Reapply after swimming, excessive perspiration, towel drying or extended sun exposure.

Warnings

For external use only. Not to be swallowed. Avoid contact with eyes.

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.

Caution: FLAMMABLE. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120 ° F (48° C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Questions or comments?

1-800-299-4789 or www.neutrogena.com

Active Ingredients

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

Inactive Ingredients

Alcohol Denat. , Isobutane, Octyldodecyl Neopentanoate, Acrylates/Octylacrylamide Copolymer, Butyloctyl Salicylate, Dimethicone, Acrylates/Dimethicone Copolymer, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Retinyl Palmitate, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Hibiscus Sabdariffa Flower Extract, Ferula Assa Foetida Root Extract, Pyrus Communis (Pear) Fruit Extract, Camellia Sinensis Leaf Extract

PRINCIPAL DISPLAY PANEL - 141 gram bottle

NEW

Neutrogena®
spectrum+
ADVANCED
sunblock spray
SPF
100+
helioplex 360
full spectrum uva-uvb™

comprehensive full spectrum
uva/uvb protection

helps prevent deep oxidative damage
ultra sheer light feel, waterproof

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT 5.0 OZ (141 g)

PRINCIPAL DISPLAY PANEL - 141 gram bottle

NEUTROGENA SPECTRUM PLUS ADVANCED SUNBLOCK   SPF 100 PLUS HELIOPLEX 360
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-406
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 30 mg  in 1 g
Homosalate (Homosalate) Homosalate 150 mg  in 1 g
Octisalate (Octisalate) Octisalate 50 mg  in 1 g
Octocrylene (Octocrylene) Octocrylene 100 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 60 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Isobutane  
Butyloctyl Salicylate  
Dimethicone  
Alpha-Tocopherol Acetate  
Octyldodecyl Neopentanoate  
Ascorbyl Palmitate  
Vitamin A Palmitate  
Feverfew  
Ferula Assa-Foetida Root  
Pear  
Green Tea Leaf  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-406-01 141 g in 1 CAN 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: 09/2010 Neutrogena Corporation



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


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