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Product NDC Code | 26052-031 | ||||
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Drug Name | Bb broad spectrum spf 15 light to medium |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part352 | ||||
Labeler Name | Burt's Bees | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 4.7% Zinc Oxide 7.0%
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 Use in the morning after cleansing Apply liberally 15 minutes before sun exposure Children under 6 months: Ask a doctor Use a water resistent sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum spf of 15 or higher and other sun protection measures including: limit time in ethe sun, especially from 10 a.m.- 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses reapply at least every 2 hours use a water resistent sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: water, glycerin, decyl oleate, isoamyl cocoate, isoamyl laurate, octyldodecanol, polyglyceryl-4 caprate, caprylic/capric triglyceride, cetyl alcohol, helianthus annuus (sunflower) seed oil, polyglyceryl-2 dipolyhydroxystearate, glyceryl stearate citrate, stearic acid, morinda citrifilia fruit extract, beeswax, jojoba esters, mica, iron oxides, silica, sorbitan stearate, stearyl alcohol, behenyl alcohol, sodium carboxymethyl C10-16 alkyl glucoside, lauryl glucoside, magnesium aluminum silicate, xanthan gum, citric acid, isostearic acid, lecithin, polyglyceryl-3polyricinoleate, polyhydroxysteric acid, sodium phytate, trihydroxystearin, alumina, arachidyl alcohol, sorbic acid, alcohol denat., potassium sorbate, sodium benzoate, fragrance*, phenoxyehtanol *natural fragrance
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 aging caused by the sun
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.BB Broad Spectrum SPF 15 Light to Medium Zinc Oxide Titanium Dioxide ISOAMYL COCOATE LECITHIN, SOYBEAN POLYGLYCERYL-3 RICINOLEATE SODIUM BENZOATE TRICAPRIN LAURYL GLUCOSIDE OCTYLDODECANOL GLYCERYL STEARATE CITRATE DOCOSANOL POTASSIUM SORBATE DECYL OLEATE POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-4 CAPRATE JOJOBA OIL ALUMINUM OXIDE ARACHIDYL ALCOHOL SORBIC ACID CITRIC ACID MONOHYDRATE PHENOXYETHANOL WATER GLYCERIN XANTHAN GUM CETYL ALCOHOL SORBITAN MONOSTEARATE STEARYL ALCOHOL SUNFLOWER OIL TRIHYDROXYSTEARIN MAGNESIUM ALUMINUM SILICATE ISOSTEARIC ACID ALCOHOL PHYTATE SODIUM SILICON DIOXIDE YELLOW WAX POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE FERRIC OXIDE RED ISOAMYL LAURATE STEARIC ACID MORINDA CITRIFOLIA FRUIT MICA TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
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.Burt's Bees BB Cream with Noni Extract LIGHT/MED Broad Spectrum SPF 15 Net Wt 1.7 oz / 48.1g BBCramLMCarton
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 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 this product from 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? (800) 849-7112 or www.burtsbees.com
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. 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