Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 100 Plus

Dosage form: aerosol, spray
Ingredients: Avobenzone 30mg in 1g, Homosalate 150mg in 1g, Octisalate 50mg in 1g, Octocrylene 100mg in 1g, Oxybenzone 60mg in 1g
Labeler: Neutrogena Corporation
NDC Code: 10812-392

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.

Neutrogena Ultra Sheer Body Mist Sunscreen
Broad Spectrum SPF 100+

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 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.

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 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 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: Ask a doctor

Other information
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Inactive ingredients

Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Alcohol Denat. , Ascorbyl Palmitate, Butyloctyl Salicylate, Cyclopentasiloxane, Diethylhexyl 2,6-Naphthalate, Fragrance, Isobutane, Retinyl Palmitate, Tocopheryl Acetate

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 100+

helioplex®
broad spectrum uva•uvb

WEIGHTLESS
CLEAN FEEL

non-greasy
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT 5.0 OZ (141 g)

NEUTROGENA ULTRA SHEER BODY MIST   SUNSCREEN BROAD SPECTRUM SPF 100 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-392
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30 mg  in 1 g
Homosalate (Homosalate) Homosalate150 mg  in 1 g
Octisalate (Octisalate) Octisalate50 mg  in 1 g
Octocrylene (Octocrylene) Octocrylene100 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ascorbyl Palmitate 
Butyloctyl Salicylate 
Cyclomethicone 5 
Diethylhexyl 2,6-Naphthalate 
Isobutane 
Vitamin A Palmitate 
.Alpha.-Tocopherol Acetate 
Packaging
#Item CodePackage Description
1NDC:10812-392-01141 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/11/2012
Labeler - Neutrogena Corporation (008254617)

Revised: 09/2012
 
Neutrogena Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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