NISEKO SUNSCREEN SPF 25- avobenzone, octinoxate, and octisalate cream

Niseko Sunscreen SPF 25 by

Drug Labeling and Warnings

Niseko Sunscreen SPF 25 by is a Otc medication manufactured, distributed, or labeled by Medimetriks Pharmaceuticals, Inc., Teligent Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Avobenzone 3.0%
Octinoxate 7.5%
Octisalate 5.0%

Purpose

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.

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.

Other information

• protect product from excessive heat and direct sun

Questions or comments?

call 1-973-882-7512

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

NISEKO SUNSCREEN SPF 25 
avobenzone, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43538-290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
C12-15 Alkyl lactate (UNII: GC844VRD7E)
butyloctyl salicylate (UNII: 2EH13UN8D3)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
isododecane (UNII: A8289P68Y2)
glycerin (UNII: PDC6A3C0OX)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetyl alcohol (UNII: 936JST6JCN)
dihexadecyl phosphate (UNII: 2V6E5WN99N)
ceteth-10 phosphate (UNII: 4E05O5N49G)
cholesterol (UNII: 97C5T2UQ7J)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
edetate disodium (UNII: 7FLD91C86K)
methylparaben (UNII: A2I8C7HI9T)
phenoxyethanol (UNII: HIE492ZZ3T)
xanthan gum (UNII: TTV12P4NEE)
green tea leaf (UNII: W2ZU1RY8B0)
C13-14 isoparaffin (UNII: E4F12ROE70)
Laureth-7 (UNII: Z95S6G8201)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43538-290-99	6 in 1 CARTON	11/15/2013
1		3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43538-290-03	1 in 1 CARTON	11/15/2013
2		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	11/15/2013

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Establishment
Name	Address	ID/FEI	Business Operations
Teligent Inc		011036910	MANUFACTURE(43538-290)