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| Product NDC Code | 71987-008 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hale cosmeceuticals complexion protection sunscreen spf 35 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Hale Cosmeceuticals, Inc. | ||||||
| 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 Ingredients Titanium Dioxide 7.5% Purpose Sunscreen
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 immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Stearic Acid, Alumina, Squalane, Borago Officinalis Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Ceteareth-20, Sodium Hyaluronate, Tocopheryl Acetate, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Olea Europaea (Olive) Fruit Oil, Hydrogenated Vegetable Oil, Tocopheryl, Urea, Cetyl Alcohol, Xanthum Gum, Disodium EDTA.
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 sun 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.Hale Cosmeceuticals Complexion Protection Sunscreen SPF 35 TITANIUM DIOXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES POLYHYDROXYSTEARIC ACID (2300 MW) STEARIC ACID ALUMINUM OXIDE SQUALANE BORAGO OFFICINALIS SEED GLYCERYL MONOSTEARATE PEG-100 STEARATE CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE GLYCERIN PHENOXYETHANOL CAPRYLYL GLYCOL SORBIC ACID OLIVE OIL TOCOPHEROL UREA CETYL ALCOHOL XANTHAN GUM EDETATE DISODIUM ANHYDROUS TITANIUM DIOXIDE TITANIUM DIOXIDE
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.Package Labeling:30ml Label2
Package Labeling:74ml Label3
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information protect this product from excessive heat and direct sun may stain some fabrics
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Visit www.halecosmeceuticals.com or call toll-free (800) 951-7005.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs
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.Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs 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