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| Product NDC Code | 54473-403 | ||||||||||
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| Drug Name | Sei bella daily uv defense broad-spectrum spf 25 sunscreen |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CREAM | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | Melaleuca 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 Ingredients Homosalate 7.5% Octocrylene 9% Octisalate 3.75% Titanium Dioxide 2% Zinc Oxide 9.45%
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 For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating 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: limiting time in the sun, especially from 10 a.m. - 2 p.m. wearing long-sleeve shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, caprylyl methicone, cyclopentasiloxane, glycerin, caprylic/capric triglyceride, coco-caprylate/caprate, propanediol, pyrus malus (apple) fruit extract, dimethicone, polymethylsilsesquioxane, lauryl peg-9 polydimethylsiloxyethyl dimethicone, PEG-12 dimethicone/PPG-20 crosspolymer, acrylates/dimethicone copolymer, C12-15 alkyl benzoate, polyhydroxystearic acid, dimethicone/peg-10/15 crosspolymer, gossypium hirsutum (cotton) extract, sodium chloride, phenoxyethanol, triethoxycaprylylsilane, ethylhexylglycerin,disteardimonium hectorite, silica, allantoin, sodium citrate, 2,3-butanediol, 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.helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer 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.Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen Sunscreen OCTOCRYLENE OCTOCRYLENE SILICON DIOXIDE ZINC OXIDE ZINC OXIDE WATER CAPRYLYL TRISILOXANE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE GLYCERIN COCO-CAPRYLATE/CAPRATE APPLE DIMETHICONE 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) DIMETHICONE/PEG-10/15 CROSSPOLYMER SODIUM CHLORIDE TRIETHOXYCAPRYLYLSILANE ETHYLHEXYLGLYCERIN DISTEARDIMONIUM HECTORITE 2,3-BUTANEDIOL TITANIUM DIOXIDE TITANIUM DIOXIDE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) PROPANEDIOL GOSSYPIUM HIRSUTUM ROOT SODIUM CITRATE ALLANTOIN PHENOXYETHANOL MEDIUM-CHAIN TRIGLYCERIDES CYCLOMETHICONE 5 ALKYL (C12-15) BENZOATE
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.Sei Bella Daily UV Defense Box.jpg Sei Bella Daily UV Defense Tube.jpg
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.
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.
Storage and handling
Information about safe storage and handling of the drug product.store at room temperature 68-77 F. Protect from freezing.
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
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