NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN  BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray 
Johnson & Johnson Consumer Inc.

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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Ultra Sheer Body Mist Sunscreen
Broad Spectrum SPF 30

Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 8%
Octisalate 4%
Octocrylene 2.35%
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 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.

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 value of SPF 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

Acrylates/ Octylacrylamide Copolymer, Acrylates/Dimethicone Copolymer, Alcohol Denat. , Ascorbyl Palmitate, Cyclopentasiloxane, Diethylhexyl 2,6 – Naphthalate, Dimethicone , Fragrance, Isobutane, PPG-5-Ceteth-20, Retinyl Palmitate, Tocopheryl Acetate, Trisiloxane

Questions or comments?

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

Dist. by Neutrogena Corporation
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 141 g Can Label

Neutrogena®

Ultra Sheer
BODY MIST
SUNSCREEN

Broad Spectrum
SPF 30

helioplex®
broad spectrum uva-uvb

WEIGHTLESS
CLEAN FEEL

Non-greasy
Water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT 5.0 OZ (141g)

Principal Display Panel - 141 g Can Label
NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN   BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-258
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate80 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate40 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene23.5 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)  
Dimethicone (UNII: 92RU3N3Y1O)  
Isobutane (UNII: BXR49TP611)  
PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Trisiloxane (UNII: 9G1ZW13R0G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10812-258-01141 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/04/201208/01/2017
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 8/2015
Document Id: d4510a36-5058-4610-9300-9bb77fc314dc
Set id: 7915955b-3c76-41d0-b218-29b13afb2c04
Version: 2
Effective Time: 20150803
 
Johnson & Johnson Consumer Inc.