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Elta MD UV Pure SPF47

Dosage form: lotion
Ingredients: titanium dioxide 55g in 1000g, zinc oxide 100g in 1000g
Labeler: Swiss American Products, Inc.
NDC Code: 60232-2582

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 Pure SPF47

Active Ingredients          Purpose

Zinc Oxide 10.0%          Sunscreen

Titanium Dioxide 5.5%   Sunscreen

Uses

  • helps prevents 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 physician if rash occurs
  • Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure
  • 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, egularly 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:

Ascorbyl Palmitate, Citric Acid, Cycloopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Potassium Sorbate, Purified Water, Silica, Sodium Chloride, Triethoxycaprylylsilane

ELTA MD UV PURE  SPF47
titanium dioxide and zinc oxide lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-2582
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
titanium dioxide (titanium dioxide) titanium dioxide55 g  in 1000 g
zinc oxide (zinc oxide) zinc oxide100 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
water 
potassium sorbate 
sodium chloride 
CITRIC ACID MONOHYDRATE 
CYCLOMETHICONE 5 
octyldodecyl neopentanoate 
ascorbyl palmitate 
dimethicone 
triethoxycaprylylsilane 
SILICON DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:60232-2582-44 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2011
Labeler - Swiss American Products, Inc. (611921669)
Registrant - Swiss American Products, Inc. (611921669)
Establishment
NameAddressID/FEIOperations
Swiss American Products, Inc.611921669manufacture(60232-2582)

Revised: 07/2012
Document Id: 9c347a1a-f20c-4a0a-bf70-596614b4bd43
Set id: 5d322bca-6fb4-4561-9f7e-9d9bcf623b1f
Version: 1
Effective Time: 20120727
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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