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| Product NDC Code | 82516-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | True Botanicals, 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 Ingredient Zinc Oxide 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 and evenly as the last step in your skincare routine, before makeup and 15 minutes before sun exposure. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating: immediately after towel drying at least every 2 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients camellia sinensis leaf (green tea) water, caprylic/capric triglyceride, coco-caprylate, glycerin*, polyglyceryl-6 stearate, capryloyl glycerin/sebacic acid copolymer, water, oryza sativa (rice) bran extract, squalane, polyhydroxystearic acid, hippophae rhamnoides (seabuckthorn) seed oil*, silybum marianum (milk thistle) ethyl ester, pisum sativum (pea) peptide, terminalia chebula fruit extract, haematococcus pluvialis (astaxanthin) powder*, simmondsia chinensis (jojoba) seed oil*, aloe barbadensis leaf juice*, camellia sinensis leaf (green tea) extract, citrus aurantium amara (bitter orange) flower distillate*, isopropyl jojobate, jojoba alcohol, jojoba esters, xanthan gum, polyglyceryl-6 behenate, lactic acid, acacia senegal gum, dipotassium glycyrrhizate, allantoin, phenethyl alcohol, ethylhexylglycerin, sodium phytate, glycerin, leuconostoc/radish root ferment filtrate, tocopherol.
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 diercted with other sun protection measures, decreasis the risk of skin cancer and wearly sighs of 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.sunscreen Skin Barrier Sun Shield SPF 30 ZINC OXIDE ZINC OXIDE WATER
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 Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask doctor Stop use and ask doctor if rash occurs
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 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 Keep out of reach of children. If swallowed get medical help or contact 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.Other Information • Protect the product in this container 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.Questions or Comments Call 1-888-4160870 M-F 9am-5pm EST
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 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 Do not use on damaged or broken skin When using this product When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor Stop use and ask doctor if rash occurs Keep out of reach of children Keep out of reach of children. If swallowed get medical help or contact 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