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| Product NDC Code | 55789-2401 | ||||
|---|---|---|---|---|---|
| Drug Name | Illuminating mineral beauty balm with spf 9 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Mineral Fusion Natural Brands 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 Ingredient Titanium Dioxide 7.4%
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. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), Caprylic/Capric Triglyceride, Jojoba Esters, Mica, Vegetable Glycerin, Sorbitan Sesquioleate, Cetearyl Olivate, Sorbitan Olivate, Potassium Cetyl Phosphate, Dimethicone, Hydroxyethylcellulose, Citric Acid, Punica Granatum (Pomegranate) Extract, Tetrahexyldecyl Ascorbate (Vitamin C), Mineral-Peptide Blend (Magnesium Asparate, Zinc Gluconate, Copper Gluconate, and Palmitoyl Tripeptide-5), Camellia Sinensis (White Tea) Leaf Extract, Aloe Barbadensis Leaf Juice, Glycyrrhiza Glabra (Licorice) Extract, Lavandula Angustifolia (Lavender) Extract, Rosa Canina (Rose) Flower Extract, Olea Europaea (Olive) Leaf Extract, Potassium Sorbate, Sodium Dehydroacetate, Sodium Benzoate, Iron Oxides (CI 77491, CI 77492, CI 77499).
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.
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.Illuminating Mineral Beauty Balm with SPF 9 Titanium Dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL MICA GLYCERIN SORBITAN SESQUIOLEATE CETEARYL OLIVATE SORBITAN OLIVATE POTASSIUM CETYL PHOSPHATE DIMETHICONE HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) CITRIC ACID MONOHYDRATE PUNICA GRANATUM ROOT BARK TETRAHEXYLDECYL ASCORBATE MAGNESIUM ASPARTATE COPPER GLUCONATE PALMITOYL TRIPEPTIDE-5 CAMELLIA SINENSIS FLOWER ALOE VERA LEAF GLYCYRRHIZA GLABRA LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP ROSA CANINA FRUIT OLEA EUROPAEA LEAF POTASSIUM SORBATE SODIUM DEHYDROACETATE SODIUM BENZOATE FERRIC OXIDE RED ZINC GLUCONATE
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.PRINCIPAL DISPLAY PANEL - 60 ml Tube Label MINERAL FUSION ® minerals on a mission ® illuminating mineral beauty balm broad spectrum SPF 9 LUMINOUS FINISH Ultra-sheer for all skin tones ALL-IN-ONE BB Makeup + moisturizer + age-defying treatment Hypo-allergenic, Fragrance free 2.0 fl oz / 60 mL e Principal Display Panel - 60 ml Tube Label
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
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call toll free 1-800-428-1668 Mon-Fri 8 AM-5 PM MST
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.Other Information Protect this product 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 Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early aging. 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. Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.
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