NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF 100 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Neutrogena Ultra Sheer Body Mist by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Body Mist 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 15%
Octisalate 5%
Octocrylene 10%
Oxybenzone 6%

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

• 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., Isobutane, Butyloctyl Salicylate, Acrylates/ Octylacrylamide Copolymer, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Fragrance, Tocopheryl Acetate, Diethylhexyl 2,6 – Naphthalate, Ascorbyl Palmitate, Retinyl Palmitate, Tocopherol

Questions or comments?

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

NewFullReach™
design
even reaches your back
Neutrogena®

Ultra Sheer®
BODY MIST
SUNSCREEN

Broad Spectrum SPF 100+
100+
helioplex®
broad spectrum uvauvb

WEIGHTLESS,
CLEAN FEEL

non-greasy
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT. 5.0 OZ. (141 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER BODY MIST   SUNSCREEN BROAD SPECTRUM SPF 100 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0300
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	150 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	100 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Isobutane (UNII: BXR49TP611)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0300-5	141 g in 1 CAN; Type 0: Not a Combination Product	10/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2009

Labeler - Johnson & Johnson Consumer Inc. (002347102)