Elta Block SPF 30 Waterproof

Dosage form: lotion
Ingredients: Octinoxate 75g in 1000g, Octisalate 50g in 1000g, Zinc Oxide 45g in 1000g
Labeler: Swiss-American Products
NDC Code: 60232-6500

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 Block SPF 30 Waterproof

Active Ingredients        Purpose
Octinoxate 7.5%..............Sunscreen
Octisalate 5.0%...............Sunscreen
Zinc Oxide 4.5%..............Sunscreen

Uses
Sunblock is super waterproof, sweatproof and will not run into your eyes and sting. Rubs in quickly, with no residual film on the skin. Broad spectrum UV-B and UV-A protection.

Warnings
For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation or rash appears, discontinue use.

Directions
Apply 30 minutes before exposure to sun. Rub in thoroughly and reapply as necessary.

Inactive Ingredients
Bees wax, hydrogenated castor oil, cetyl dimethicone, cetyl dimethicone copolyol (and) polyglyceryl-4 isostearate (and) hexyl laurate, disodium EDTA, isopropyl myristate, isopropyl palmitate, methylparaben, paraffin, petrolatum, sodium chloride, propylene glycol, propylparaben, water.

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ELTA BLOCK  SPF 30 WATERPROOF
zinc oxide, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-6500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate75 g  in 1000 g
Octisalate (Octisalate) Octisalate50 g  in 1000 g
Zinc Oxide (Zinc Oxide) Zinc Oxide45 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
Water 
Edetate Disodium 
Sodium Chloride 
Methylparaben 
Propylparaben 
Propylene Glycol 
Isopropyl Myristate 
Isopropyl Palmitate 
Yellow Wax 
Hydrogenated Castor Oil 
Hexyl Laurate 
Polyglyceryl-4 Isostearate 
Triethoxycaprylylsilane 
Packaging
#Item CodePackage Description
1NDC:60232-6500-385 g in 1 TUBE
2NDC:60232-6500-8240 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/30/2002
Labeler - Swiss-American Products (611921669)
Registrant - Swiss-American Products (611921669)
Establishment
NameAddressID/FEIOperations
Swiss-American Products611921669manufacture

Revised: 03/2010
 
Swiss-American Products

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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