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Product NDC Code | 82516-202 | ||||
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Drug Name | Sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | True Botanicals | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 18%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aloe barbadensis leaf juice, squalane, polyglyceryl-3 diisostearate, caprylic/capric triglyceride, glyceryl caprylate, polyhydroxystearic acid, sesamum indicum (sesame) seed oil, sodium chloride, silybum marianum (milk thistle) ethyl ester, pisum sativum (pea) peptide, terminalia chebula fruit extract, rubus idaeus (raspberry) seed oil, niacinamide, glycerin, sclerotium gum, caprylhydroxamic acid, allantoin, leuconostoc/radish root ferment filtrate, tocopherol. May Contain: titanium dioxide, iron oxides
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, decreases the risk of sun cancer and early signs 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 Everyday Skin Tint 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.Everyday Skin Tint label Everyday Skin Tint label
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.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 1-888-416-0870 M-F 9am-5pm EST
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 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 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 When using product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash occurs 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