FDA Label for Niseko Sunscreen Spf 25
View Indications, Usage & Precautions
Niseko Sunscreen Spf 25 Product Label
The following document was submitted to the FDA by the labeler of this product Medimetriks Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Mfd. by: IGI Laboratories, Inc., Buena, NJ 08310
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
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes.
Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
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
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.
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