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| Product NDC Code | 83677-610 | ||||
|---|---|---|---|---|---|
| Drug Name | Hale and hush broad spectrum spf 30 spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Eclectic Solutions 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.Zinc Oxide 13.50%
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 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 broad spectrum spf of 15 or higher and other sun protection measure including: limit time in the sun, especially from 10am to 2 pm wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a doctor
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, Polyglycery1-10 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.* Help 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 th
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Hale and Hush Broad Spectrum SPF 30 SPF 30 Zinc Oxide PHELLODENDRON AMURENSE BARK POLYGLYCERYL-10 STEARATE LECITHIN, SOYBEAN MALIC ACID, L- PEG-60 GLYCERYL STEARATE POLYHYDROXYSTEARIC ACID (2300 MW) .ALPHA.-TOCOPHEROL ACETATE, D- WITCH HAZEL DOCOSANOL SODIUM LACTATE CITRIC ACID MONOHYDRATE MACADAMIA OIL CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE ISODECYL NEOPENTANOATE ALEURITES MOLUCCANA SEED PORPHYRA UMBILICALIS GLYCERYL ISOSTEARATE POTASSIUM CETYL PHOSPHATE CETOSTEARYL ALCOHOL HYPROMELLOSES ERGOTHIONEINE SANDALWOOD GLYCERIN WATER BARLEY ALCOHOL LONICERA CAPRIFOLIUM FLOWER HYDROGENATED PALM GLYCERIDES LEVOMENOL HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) ZINC OXIDE ZINC OXIDE ETHYL MACADAMIATE SODIUM STEAROYL LACTYLATE FYTIC ACID SODIUM HYDROXIDE
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.Label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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 swallowed, get medical help or contact a poison 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.Protect this product from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.602-858-5814 haleandhush.com Distributed by Eclectic Solutions LLC 4820 South Ash Ave #102 Tempe AZ 85282
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
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.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. Keep out of reach of children. If swallowed, get medical help or contact a poison 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