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| Product NDC Code | 83657-610 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sheer protection spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Skin Script, LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s): Zinc Oxide (13.5%)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions: Apply liberally 15 min before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours Children under 6 months: Ask a doctor. 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 10am - 2pm. Wear long sleeve shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: Helps prevent sunburn If used as directed with other protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Purpose: Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sheer Protection SPF 30 Zinc Oxide ETHYL MACADAMIATE PEG-60 GLYCERYL STEARATE PORPHYRA UMBILICALIS PHELLODENDRON AMURENSE BARK GLYCERYL ISOSTEARATE .ALPHA.-TOCOPHEROL ACETATE, D- LECITHIN, SOYBEAN SODIUM HYDROXIDE WITCH HAZEL HYDROGENATED PALM GLYCERIDES ALCOHOL DOCOSANOL HYPROMELLOSES SODIUM LACTATE CITRIC ACID MONOHYDRATE ZINC OXIDE ZINC OXIDE LEVOMENOL SODIUM STEAROYL LACTYLATE SANDALWOOD LONICERA CAPRIFOLIUM FLOWER POTASSIUM CETYL PHOSPHATE CETOSTEARYL ALCOHOL WATER CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE GLYCERIN POLYHYDROXYSTEARIC ACID (2300 MW) BARLEY HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) ISODECYL NEOPENTANOATE ALEURITES MOLUCCANA SEED POLYGLYCERYL-10 STEARATE MALIC ACID, L- MACADAMIA OIL ERGOTHIONEINE FYTIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PDP
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: Protect the product from excessive heat and direct sun.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 the product is swallowed, get medical help or contact a Posion Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API