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| Product NDC Code | 14268-120 | ||||
|---|---|---|---|---|---|
| Drug Name | Summary everyday mineral sunscreen broad spectrum spf 30 |
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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 | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | ENGLEWOOD LAB, 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 Titanium Dioxide 3.64% Zinc Oxide 2.98% Purposes 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 Apply generously 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Diemthicone, Caprylic/Capric Triglyceride, Glycerin, Aloe Barbadensis Leaf Juice, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Fragrance, Rubus Idaeus(Raspberry) Seed Extract, Chondrus Crispus Extract, Oryza Sativa (Rice) Extract, Spirulina Platensis Extract, Spirulina Maxima Extract, Panax Ginseng Root Extract, Alumina, Hyaluronic Acid, Leuconostoc/Radish Root Ferment Filtrate, Sodium Potassium Aluminum Silicate, Polyhydroxystearic Acid, Stearic Acid, Triethoxycaprylylsilane, Superoxide Dismutase, Soybean Peroxidase, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Aminomethyl Propanol, Titanium Dioxide, Xanthan Gum, Sodium Carbomer, Citric 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.Purposes Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE WATER DIMETHICONE MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN ALOE VERA LEAF NIACINAMIDE SILICON DIOXIDE RUBUS IDAEUS SEED CHONDRUS CRISPUS CARRAGEENAN RICE GERM ARTHROSPIRA MAXIMA ASIAN GINSENG ALUMINUM OXIDE HYALURONIC ACID LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE STEARIC ACID TRIETHOXYCAPRYLYLSILANE SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) BENZYL ALCOHOL POTASSIUM SORBATE SODIUM BENZOATE AMINOMETHYLPROPANOL XANTHAN GUM CITRIC ACID MONOHYDRATE 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: Outer Package4 Inner Package4
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 the product in this container 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.
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 ir 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.
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 ir rash occurs Keep out of reach of children.
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