NEUTROGENA WET SKIN SWIM HUMIDITY SWEAT SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Neutrogena Wet Skin Swim Humidity Sweat by

Drug Labeling and Warnings

Neutrogena Wet Skin Swim Humidity Sweat by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 8%
Octisalate 4%
Octocrylene 8%
Oxybenzone 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

• For external use only

• Do not use on damaged or broken skin

• When using this product
  • keep away from face to avoid breathing it
  • keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs

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

• Danger: 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.

Directions

• shake well before and frequently during use
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• apply to all skin exposed to the sun
• hold container 4-6 inches from the skin to apply. Rub in.
• do not spray directly into face. Spray on hands and then apply to face. Rub in.
• do not apply in windy conditions
• use in a well-ventilated area
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants hats, and sunglasses
• children under 6 months of age: Ask a doctor

Other information

• protect this product from excessive heat and direct sun
• may stain some fabrics

Inactive ingredients

alcohol denat., dimethyl ether, octyldodecyl citrate crosspolymer, ethyl methicone, acrylates/octylacrylamide copolymer, dimethicone, acrylates/dimethicone copolymer, fragrance, tocopheryl acetate, cetyl dimethicone/bis-vinyldimethicone crosspolymer, nelumbo nucifera flower wax, diethylhexyl 2,6-naphthalate, ascorbyl palmitate, retinyl palmitate, tocopherol

Questions?

Visit www.neutrogena.com or call toll-free 800-299-4786 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 141 g Can Label

Neutrogena®
wet skin
SWIM.HUMIDITY.SWEAT
SUNSCREEN
 Broad
 Spectrum
 SPF 30

helioplex®
broad spectrum uva-uvb

full strength protection
on wet or dry skin
 water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT 5.0 OZ (141g)

INGREDIENTS AND APPEARANCE

NEUTROGENA WET SKIN SWIM HUMIDITY SWEAT   SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	80 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Dimethyl Ether (UNII: AM13FS69BX)
Ethyl Methicone (8 Mpa.S) (UNII: 3YWG8XYT8H)
Dimethicone (UNII: 92RU3N3Y1O)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Nelumbo Nucifera Flower Wax (UNII: U01S6C427I)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0175-5	141 g in 1 CAN; Type 0: Not a Combination Product	10/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)