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| Product NDC Code | 83872-100 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Bulubiu mineral sunscreen |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | CREAM | ||||||||||||||||
| Application Number | M020 | ||||||||||||||||
| Labeler Name | Shenzhen XiaoMai Manufacturing Co., Ltd. | ||||||||||||||||
| 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 Homosalate: 10% Titanium Dioxide: 5% Octocrylene: 2% Zinc Oxide: 9% Niacinamide: 4% Ceramide 3: 0.5% Ceramide 6 II: 0.5% Ceramide 1: 0.5% Sodium Hyaluronate: 1.5% Collagen: 1.5% Centella Asiatica Extract: 2.5%
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 use apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Cetearyl Alcohol: 4.5% Ethylcellulose: 1% Carbomer: 0.2% Disodium EDTA: 0.6% Glycerin: 5.5% Dimethicone: 3.5% Behentrimonium Methosulfate: 1.5% Aluminum Starch Octenylsuccinate: 2% Propylparaben: 0.6% Sodium Lauroyl Aspartate: 0.3% Phytosphingosine: 0.2% Lactic Acid: 0.2% Xanthan Gum: 0.2% Aqua: 42.7%
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 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 helps prevent sunburn.
Spl product data elements
Usually a list of ingredients in a drug product.bulubiu mineral sunscreen mineral sunscreen GLYCERIN OCTOCRYLENE OCTOCRYLENE NIACINAMIDE NIACINAMIDE ETHYLCELLULOSES WATER ZINC OXIDE ZINC OXIDE DIMETHICONE PHYTOSPHINGOSINE XANTHAN GUM BEHENTRIMONIUM METHOSULFATE LACTIC ACID HOMOSALATE HOMOSALATE TITANIUM DIOXIDE TITANIUM DIOXIDE CERAMIDE 3 CERAMIDE 3 PROPYLPARABEN SODIUM LAUROYL ASPARTATE CERAMIDE 1 CERAMIDE 1 CERAMIDE 6 II CERAMIDE 6 II
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.PAC
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 medicalhelp 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.Do not use on damaged or broken skin.
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.Other Information Protect the product in this container from excessive heat and direct sun.
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.
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