Label: NISEKO SUNSCREEN SPF 25- avobenzone, octinoxate, and octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43538-290-03, 43538-290-99 - Packager: Medimetriks Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 10, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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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
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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
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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
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
NISEKO SUNSCREEN SPF 25
avobenzone, octinoxate, and octisalate creamProduct 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)