Niseko Sunscreen SPF 25 description, usages, side effects, indications, overdosage, supplying and lots more!

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Niseko Sunscreen SPF 25

Medimetriks Pharmaceuticals, Inc.

Niseko™ Sunscreen SPF 25


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Avobenzone 3.0%
Octinoxate 7.5%
Octisalate 5.0%

Purpose

Sunscreen

Niseko Sunscreen SPF 25 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.

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.

Directions

  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply:
    • at least every 2 hours
    • use water-resistant sunscreen if swimming or sweating
  • 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 doctor

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.

Niseko Sunscreen SPF 25 Other information

  • protect product from excessive heat and direct sun

Questions or comments?

call 1-973-882-7512

Mfd. by: IGI Laboratories, Inc., Buena, NJ 08310

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

niseko™

SUNSCREEN

Broad Spectrum
SPF 25

UVA/UVB Protection

Formulated with
Green & White Tea • Vitamin E

Dermatologist-tested
Non-comedogenic

Net Wt. 3 oz (85 g)

MEDIMETRIKS
PHARMACEUTICALS, INC.

Niseko Sunscreen SPF 25

Niseko Sunscreen SPF 25

Avobenzone, Octinoxate, and Octisalate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43538-290
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 30 mg
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 50 mg

Inactive Ingredients

Ingredient Name Strength
water
C12-15 ALKYL LACTATE
BUTYLOCTYL SALICYLATE
GLYCERYL STEARATE SE
ISODODECANE
GLYCERIN
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
DIHEXADECYL PHOSPHATE
CETETH-10 PHOSPHATE
CHOLESTEROL
.ALPHA.-TOCOPHEROL ACETATE
EDETATE DISODIUM
METHYLPARABEN
PHENOXYETHANOL
XANTHAN GUM
GREEN TEA LEAF
C13-14 ISOPARAFFIN
LAURETH-7

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 3 in 1 TUBE
2 85 in 1 TUBE
3 NDC:43538-290-03 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-11-15


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