Elta MD UV Aero SPF45

Dosage form: aerosol, spray
Ingredients: zinc oxide 93g in 1000g, octinoxate 75g in 1000g
Labeler: Swiss American Products, Inc.
NDC Code: 60232-2587

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.

Elta MD UV Aero SPF45

Active Ingredients         Purpose

Zinc Oxide 9.3%           Sunscreen

Octinoxate 7.5%           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; not to be swallowed
  • do not use on damaged or broken skin
  • Do not spray directly on face
  • When using this product keep out of eyes.  Avoid inhaling.  Avoid spraying into eyes or onto other mucous membranes.  Rinse with water to remove.
  • Stop use and ask a physician if signs of irritation or rash appear.
  • Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Flammable. Contents under pressure. Do not use near fire, heat or while smoking.  Do not puncture or incinerate.  Store at temperature below 120F (49C).  Use only as directed.  Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.  Hard surfaces may become damp when product is sprayed.  Avoid slips or falls.

Directions

  • Shake well before use
  • Apply liberally 15 minutes before sun exposure
    • do not apply in windy conditions
    • hold can (upright or inverted) 4 to 6 inches away from body and apply liberally, spraying slowly and evenly until product is visible on skin.  Gently rub in.  Do not spray in face.  Spray into hand and apply to the face.
  • Use in well ventilated areas.
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Sun Protection Measures. Spending time int he sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad-spectrum 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-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a physician.

Inactive Ingredients

Butylene Glycol, Capryloyl Glycine, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Isobutane, Lauryl PEG-9 Polymethylsiloxyethyl Diemthicone, Phenoxyethanol, Propane, Purified Water, Sodium Chloride, Triethoxycaprylylsilane, Undecylenoyl Glycine

ELTA MD UV AERO  SPF45
zinc oxide and octinoxate aerosol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-2587
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
zinc oxide (zinc oxide) zinc oxide93 g  in 1000 g
octinoxate (octinoxate) octinoxate75 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
isobutane 
propane 
butylene glycol 
phenoxyethanol 
capryloyl glycine 
undecylenoyl glycine 
CYCLOMETHICONE 5 
water 
sodium chloride 
triethoxycaprylylsilane 
Packaging
#Item CodePackage Description
1NDC:60232-2587-66 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2012
Labeler - Swiss American Products, Inc. (611921669)
Registrant - Swiss American Products, Inc. (611921669)
Establishment
NameAddressID/FEIOperations
Swiss American Products, Inc.611921669manufacture(60232-2587)

Revised: 07/2012
 
Swiss American Products, Inc.

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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