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Elta MD UV SPF46 SPF46

Dosage form: spray
Ingredients: zinc oxide 93g in 1000g, octinoxate 75g in 1000g
Labeler: Swiss American Products, Inc.
NDC Code: 60232-2585

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 Spray SPF46

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.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes.  Rinse with water to remove.
  • Top 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.
  • 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.  Gently rub in.
  • 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 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, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Sodium Chloride, Triethoxycaprylylsilane, Undecylenoyl Glycine

ELTA MD UV SPF46  SPF46
zinc oxide and octinoxate sunscreen spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-2585
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
butylene glycol 
phenoxyethanol 
capryloyl glycine 
undecylenoyl glycine 
CYCLOMETHICONE 5 
water 
sodium chloride 
triethoxycaprylylsilane 
Packaging
#Item CodePackage Description
1NDC:60232-2585-44 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2010
Labeler - Swiss American Products, Inc. (611921669)
Registrant - Swiss American Products, Inc. (611921669)
Establishment
NameAddressID/FEIOperations
Swiss American Products, Inc.611921669manufacture(60232-2585)

Revised: 07/2012
Document Id: 79af99c3-2738-494f-9d92-04c8aa606a91
Set id: 6c94696a-8a16-4f69-97b7-29ee1aff48c0
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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