Indications and 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
Niseko Sunscreen SPF 25
- Manufacturer
- Medimetriks Pharmaceuticals, Inc. | Teligent Inc
- Effective date
- 2018-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:58:04
Label at a glance#
ProductNiseko Sunscreen SPF 25
Active ingredientAvobenzone, Octinoxate, Octisalate
Label structure11 sections
Dosage and administration
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: limi...
Storage and handling
protect product from excessive heat and direct sun
Contacts and useful links#
Label contents#
Full prescribing information#
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
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin
OTC - WHEN USING SECTION
When using this product keep out of eyes.
Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43538-290-03 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4ce5-a910-e053-dadaa90a0b85 | Niseko™ Sunscreen SPF 25 |
| 43538-290-99 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4ce5-a910-e053-dadaa90a0b85 | Niseko™ Sunscreen SPF 25 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43538-290-03 | Niseko Sunscreen SPF 25 | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 43538-290-03 | Niseko Sunscreen SPF 25 | 85 g in 1 TUBE | CREAM | 85 | 2 | |
| 43538-290-99 | Niseko Sunscreen SPF 25 | 6 in 1 CARTON | CREAM | 6 | 2 | |
| 43538-290-99 | Niseko Sunscreen SPF 25 | 3 g in 1 TUBE | CREAM | 3 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| Avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| .alpha.-tocopherol acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| butyloctyl salicylate | INACTIVE INGREDIENT | 2EH13UN8D3 | 1 | |
| C12-15 Alkyl lactate | INACTIVE INGREDIENT | GC844VRD7E | 1 | |
| C13-14 isoparaffin | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| ceteth-10 phosphate | INACTIVE INGREDIENT | 4E05O5N49G | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| cholesterol | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| dihexadecyl phosphate | INACTIVE INGREDIENT | 2V6E5WN99N | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Glyceryl Stearate SE | INACTIVE INGREDIENT | FCZ5MH785I | 1 | |
| green tea leaf | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| isododecane | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| Laureth-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Niseko Sunscreen SPF 25
- Avobenzone, Octinoxate, and Octisalate
- Avobenzone
- Octinoxate
- Octisalate
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43538-290 | 43538-290-99, 43538-290-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Glyceryl Stearate SE | GLYCERYL STEARATE SE | FCZ5MH785I | LOTION / TOPICAL | 46 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | CREAM / TOPICAL | 1 %w/w | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| Glyceryl Stearate SE | GLYCERYL STEARATE SE | FCZ5MH785I | CREAM / TOPICAL | 4 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | LOTION / TOPICAL | 3627 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET / ORAL | NA | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAMUSCULAR | 10 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | SUPPOSITORY / VAGINAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL | 7 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 0.32 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e81419d5-5f8b-43a6-9b1e-c57eb03a916e | b782e60f-ab5f-4e71-a3d5-76c8367487c4 | 2018-12-10 | Warnings | e81419d5-5f8b-43a6-9b1e-c57eb03a916e b782e60f-ab5f-4e71-a3d5-76c8367487c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.