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| Product NDC Code | 65278-619 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mineral sun defense moisturizer broad spectrum sunscreen spf 30 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PASTE | ||||||
| Application Number | M020 | ||||||
| Labeler Name | June Jacobs Labs, 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................4.31% Zinc Oxide .......................19.27%
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 • Reapply every 2 hours • Use a water resistant sunscreen if swimming or sweating • Children under 6 months of age: 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 Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco-Caprylate/Caprate, Behenyl Behenate, Sorbitol/ Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.
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 cause 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.Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide ETHYL MACADAMIATE ORANGE OIL LAUROYL LYSINE ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE COCO-CAPRYLATE/CAPRATE GERANIUM OIL, ALGERIAN TYPE AVOCADO OIL TITANIUM DIOXIDE TITANIUM DIOXIDE TOCOPHEROL ALUMINUM OXIDE SACCHAROMYCES CEREVISIAE OCTYLDODECYL ERUCATE SUNFLOWER OIL GLYCERYL CAPRYLATE AMYRIS BALSAMIFERA OIL VETIVER OIL STEARIC ACID SHEA BUTTER GLYCERIN GLYCERYL 1-UNDECYLENATE MALIC ACID CASTOR OIL LINALOOL, (+/-)- GALBANUM DILINOLEIC ACID/BUTANEDIOL COPOLYMER GREEN TEA LEAF PUNICA GRANATUM ROOT BARK CANDELILLA WAX LAVANDIN OIL POLYGLYCERYL-6 POLYRICINOLEATE VITIS VINIFERA SEED LYCIUM BARBARUM FRUIT CITRAL LITSEA OIL POGOSTEMON CABLIN LEAF OIL GINGER OIL ASPALATHUS LINEARIS LEAF LIMONENE, (+)- BEHENYL BEHENATE POLYHYDROXYSTEARIC ACID (2300 MW) JUNIPER BERRY OIL FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) Nude/Beige
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.Mineral Sun Defense carton Mineral Sun Defense Tube
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 right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • Protect the product in this container from excessive heat and direct sun
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 1-866-586-3522
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. Stop use and ask a doctor if rash occurs.
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