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Name:Neutrogena Wet Skin Swim-humidity-sweat Sunblock Spf 50 Helioplex
Manufacturer:Neutrogena Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Neutrogena Wet Skin Swim-Humidity-Sweat Sunblock Spray SPF 50

NEUTROGENA WET SKIN SWIM-HUMIDITY-SWEAT SUNBLOCK  SPF 50 HELIOPLEX - 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 Wet Skin Swim-Humidity-Sweat Sunblock Spray SPF 50

Directions

For best results, apply 15-30 minutes before sun exposure. Hold Can 4-6 inches away from body and apply liberally, spraying slowly and evenly until product is visible on skin. Can be applied directly to wet skin. Reapply after swimming, excessive perspiration, towel drying or extended sun exposure. Do not apply in windy conditions. Do not spray into face. Spray into hand and apply to the face. Use in well ventilated areas.

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 10%, Octisalate 5%, Octocrylene 10%, Oxybenzone 5%

Inactive Ingredients

 
Alcohol Denat.
 
Dimethyl Ether
 
Octyldodecyl Citrate Crosspolymer
 
Acrylates/Octylacrylamide Copolymer
 
Ethyl Methicone
 
Cetyl Dimethicone/Bis-Vinyl Dimethicone Crosspolymer
 
Dimethicone
 
Acrylates/Dimethicone Copolymer
 
Fragrance
 
Tocopheryl Acetate
 
Nelumbo Nucifera Flower Wax
 
Diethylhexyl 2,6-Naphthalate
 
Ascorbyl Palmitate
 
Retinyl Palmitate

PRINCIPAL DISPLAY PANEL - 141 g Bottle Label

NEW

Neutrogena®

wet skin

SWIM-HUMIDITY-SWEAT

sunblock spray

SPF
50

helioplex®
broad spectrum uva-uvb

full strength protection
even on wet skin
applies to wet or dry skin
sweatproof, waterproof

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT 5.0 OZ (141 g)

Principal Display Panel - 141 g Bottle Label

NEUTROGENA WET SKIN SWIM-HUMIDITY-SWEAT SUNBLOCK   SPF 50 HELIOPLEX
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-969
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 100 mg  in 1 g
Octisalate (Octisalate) Octisalate 50 mg  in 1 g
Octocrylene (Octocrylene) Octocrylene 100 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Alcohol  
Dimethyl Ether  
Dimethicone  
.alpha.-tocopherol acetate, dl-  
Ascorbyl Palmitate  
Vitamin A Palmitate  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10812-969-01 141 g in 1 CAN None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 12/01/2010

Labeler - Neutrogena Corporation (008254617)

Revised: 08/2010 Neutrogena Corporation



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


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