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| Product NDC Code | 69039-630 | ||||
|---|---|---|---|---|---|
| Drug Name | Sun bum mineral sunscreen spf 50 |
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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 | LIQUID | ||||
| Application Number | part352 | ||||
| Labeler Name | Sun Bum LLC | ||||
| 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 3.4%, Zinc oxide 16% 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 shake well before use. hold container 4 to 6 inches from the skin to apply spray liberally and spread evenly by hand 15 minutes before sun exposure do not spray directly into face. spray on hands then apply to face do not apply in windy conditions use in well-ventilated area Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours •children under 6 months: ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, butyloctyl salicylate, helianthus annuus (sunflower) seed oil, dicaprylyl carbonate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, polyester-8, sodium stearoyl glutamate, coco-glucoside, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, tocopherol, glycerin, cellulose gum, bentonite, microcrystalline cellulose, caprylyl glycol, silica, polyhydroxystearic acid, citric acid, alumina, bisabolol, sodium gluconate, caprylhydroxamic acid
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.Sun Bum Mineral Sunscreen SPF 50 TITANIUM DIOXIDE, ZINC OXIDE WATER BUTYLOCTYL SALICYLATE SUNFLOWER OIL DICAPRYLYL CARBONATE PROPANEDIOL ISOCETYL STEAROYL STEARATE METHYL DIHYDROABIETATE CETOSTEARYL ALCOHOL POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) SODIUM STEAROYL GLUTAMATE COCO GLUCOSIDE ALOE VERA LEAF BANANA TOCOPHEROL GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED BENTONITE MICROCRYSTALLINE CELLULOSE CAPRYLYL GLYCOL SILICON DIOXIDE POLYHYDROXYSTEARIC ACID (2300 MW) CITRIC ACID MONOHYDRATE ALUMINUM OXIDE LEVOMENOL SODIUM GLUCONATE CAPRYLHYDROXAMIC ACID TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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: 50
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
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-978-6286
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. use only as directed. Interntional misuse by delibarately concentrating and inhaling the contents can be harmful or fatal. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
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. use only as directed. Interntional misuse by delibarately concentrating and inhaling the contents can be harmful or fatal. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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