FDA Label for Niseko Sunscreen Spf 25
View Indications, Usage & Precautions
Niseko Sunscreen Spf 25 Product Label
The following document was submitted to the FDA by the labeler of this product Medimetriks Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Rx Only
Sumadan®
(Sodium Sulfacetamide 9% & Sulfur 4.5%)
WASH
In a Moisturizing
Novasome® Vehicle
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Keep out of reach of children. Keep bottle tightly closed.
niseko™
SUNSCREEN
Broad Spectrum SPF 25
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Manufactured for:
Medimetriks Pharmaceuticals, Inc., 383 Route 46 West, Fairfield, NJ 07004-2402 USA
www.medimetriks.com • MADE IN USA
Ingredients
Each gram of SUMADAN® Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.
Storage And Handling
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
Active Ingredients
Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%.
Inactive Ingredients
Purified Water, Cyclomethicone, C12-15 Alkyl Lactate, Butyloctyl Salicylate, Glyceryl Stearate SE, Isododecane, Glycerin, Cetearyl Alcohol, Butylene/Ethylene/Propylene Copolymer, Polyacrylamide, Cetyl Alcohol, Dicetyl Phosphate, Ceteth-10 Phosphate, Cholesterol, Tocopheryl Acetate, Edetate Disodium, Methylparaben, Phenoxyethanol, Xanthan Gum, Camellia Sinensis Leaf (Green Tea) Extract, Camellia Sinensis Leaf (White Tea) Extract, C13-C14 Isoparaffin, Laureth-7.
Principal Display Panel - Kit Carton
NDC 43538-192-16
Rx Only
Sumadan®
(Sodium Sulfacetamide 9% & Sulfur 4.5%)
XLT
KIT CONTENTS:
1 - Sumadan® (Sodium Sulfacemide 9% & Sulfur 4.5%) Wash (Net Wt. 16 oz.)
1 - Niseko™ Sunscreen Broad Spectrum SPF 25 (Net Wt. 3 oz.)
MEDIMETRIKS
PHARMACEUTICALS, INC.
* Please review the disclaimer below.
