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| Product NDC Code | 26052-492 | ||||
|---|---|---|---|---|---|
| Drug Name | Burts bees calming day spf30 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Burts Bees | ||||
| 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 16.9% 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 Reapply Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly us a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10a.m.-2p.m., wear long-sleeved 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: water, caprylic/capric triglyceride, glycerin, polyglyceryl-6 stearate, C13-15 alkane, pentylene glycol, mica, c15-19 alkane, silica, cetearyl nonanoate, inulin, squalane, polyhydroxystearic acid, carthamus tinctorius (safflower) seed oil, simmondsia chinensis (jojoba) seed oil, aloe barbadensis leaf juice, honey, argania spinosa kernel oil, saccharomyces ferment, beeswax, oryza sativa (rice) extract, acacia senegal gum, tocopheryl acetate, polyglyceryl-6 behenate, stearyl alcohol, cetyl alcohol, xanthan gum, glyceryl laurate, sodium PCA, sodium citrate, citric acid, sodium phytate, bisabolol, potassium sorbate, fructose, glucose, inositol, sucrose, trehalose, myristyl alcohol, arachidyl alcohol, benzoic acid, sodium benxoate, hydroxyacetophenone
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.Burts Bees Calming Day SPF30 Zinc OXide SODIUM PYRROLIDONE CARBOXYLATE YELLOW WAX ACACIA SODIUM CITRATE CITRIC ACID MONOHYDRATE LEVOMENOL HEXASODIUM PHYTATE HONEY RICE GERM ZINC OXIDE ZINC CATION WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE PENTYLENE GLYCOL MICA C15-19 ALKANE SILICON DIOXIDE CETEARYL NONANOATE INULIN SQUALANE SAFFLOWER OIL CETOSTEARYL ALCOHOL JOJOBA OIL POLYHYDROXYSTEARIC ACID (2300 MW) ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE ALOE HYDROXYACETOPHENONE XANTHAN GUM POLYGLYCERYL-6 BEHENATE GLYCERYL LAURATE
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.CTNCALMING
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 broken or damaged 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
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 product is swalloed, 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 this product from excessive hear and direct sun.
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. Stop use and ask a doctor if rash occurs.
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 broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.
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