NISEKO SUNSCREEN SPF 25- avobenzone, octinoxate, and octisalate cream 
Medimetriks Pharmaceuticals, Inc.

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.

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Niseko™ Sunscreen SPF 25

Drug Facts

Active Ingredient

Avobenzone 3.0%
Octinoxate 7.5%
Octisalate 5.0%

Purpose

Sunscreen

Uses

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

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

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.

Principal Display Panel - 85 g Tube Carton
NISEKO SUNSCREEN SPF 25 
avobenzone, octinoxate, and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43538-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43538-290-996 in 1 CARTON11/15/2013
13 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:43538-290-031 in 1 CARTON11/15/2013
285 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/15/2013
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
Establishment
NameAddressID/FEIBusiness Operations
Teligent Inc011036910MANUFACTURE(43538-290)

Revised: 12/2018
Document Id: e81419d5-5f8b-43a6-9b1e-c57eb03a916e
Set id: b782e60f-ab5f-4e71-a3d5-76c8367487c4
Version: 2
Effective Time: 20181210
 
Medimetriks Pharmaceuticals, Inc.