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Product NDC Code | 83249-002 | ||||
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Drug Name | Rms supernatural radiance serum spf 30 sunscreen medium aura |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | EMULSION | ||||
Application Number | M020 | ||||
Labeler Name | Rms organics LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Zinc Oxide 20%
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: at least every 2 hours for sun protection use a water resistant suncreen 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: limit tine in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua/Eau, Caprylic/Capric Triglyceride, Isononyl Isononanoate, C9-12 Alkane, Glycerin, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Crambe Abyssinica Seed Oil, Coco-Caprylate/Caprate, Polyglyceryl-3 Oleate, Magnesium Sulfate, Silica, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Potassium Sorbate, Caprylyl Glycol, Ethylhexylglycerin, Niacinamide, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Olea Europaea Olive) Fruit Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pisum Sativum (Pea) Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Tocopherol, Benzyl Alcohol, Beta-Carotene, Xanthophylls, Chenopodium Quinoa Seed Extract, Lavandula Angustifolia (Lavender) Oil, Juniperus Virginiana Oil, Pelargonium Graveolens Flower Oil, Sodium Benzoate, Copaifera Officinalis (Balsam Copaiba) Resin, Polygonum Cuspidatum Root Extract, Portulaca Oleracea Extract, Glycine Soja (Soybean) Oil, Artemisia Vulgaris Oil, Myrtus Communis Oil, Pelargonium Capitatum Leaf Extract, Rosa Damascena Flower Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Limonene, Linalool, Citronellol, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491). May Contain: Iron Oxides (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 If used as directed with other sun protective 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.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.RMS SUPERNATURAL RADIANCE SERUM SPF 30 SUNSCREEN MEDIUM AURA ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES ISONONYL ISONONANOATE GLYCERIN DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE POTASSIUM SORBATE WATER PURSLANE SOYBEAN OIL LAVENDER OIL OLIVE OIL CHENOPODIUM QUINOA SEED PELARGONIUM GRAVEOLENS FLOWER OIL SODIUM BENZOATE SUNFLOWER OIL BUTYLENE GLYCOL BERGAMOT OIL PEA LUTEIN JUNIPERUS VIRGINIANA OIL COPAIFERA OFFICINALIS RESIN POLYGONUM CUSPIDATUM ROOT ARTEMISIA VULGARIS TOP OIL MAGNESIUM SULFATE, UNSPECIFIED CAPRYLYL GLYCOL NIACINAMIDE SQUALANE MICA TITANIUM DIOXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE MYRTLE LEAF OIL PELARGONIUM CAPITATUM LEAF ROSA DAMASCENA FLOWER OIL LIMONENE, (+)- LINALOOL, (+)- .BETA.-CITRONELLOL, (R)- FERRIC OXIDE YELLOW POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE COCO-CAPRYLATE/CAPRATE POLYGLYCERYL-3 OLEATE BETA CAROTENE ORANGE OIL GALBANUM OIL ROSEMARY TOCOPHEROL BENZYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL SILICON DIOXIDE ETHYLHEXYLGLYCERIN ZINC OXIDE ZINC OXIDE RMS SUPERNATURAL RADIANCE SERUM SPF 30 SUNSCREEN LIGHT AURA ZINC OXIDE BERGAMOT OIL PEA LUTEIN JUNIPERUS VIRGINIANA OIL COPAIFERA OFFICINALIS RESIN ARTEMISIA VULGARIS TOP OIL SQUALANE MAGNESIUM SULFATE, UNSPECIFIED CAPRYLYL GLYCOL NIACINAMIDE MICA TITANIUM DIOXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE LIMONENE, (+)- MYRTLE LEAF OIL MEDIUM-CHAIN TRIGLYCERIDES ISONONYL ISONONANOATE GLYCERIN DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE POTASSIUM SORBATE POLYGONUM CUSPIDATUM ROOT WATER PURSLANE SOYBEAN OIL LAVENDER OIL OLIVE OIL CHENOPODIUM QUINOA SEED PELARGONIUM GRAVEOLENS FLOWER OIL SODIUM BENZOATE SUNFLOWER OIL BUTYLENE GLYCOL PELARGONIUM CAPITATUM LEAF ROSA DAMASCENA FLOWER OIL ORANGE OIL GALBANUM OIL BENZYL ALCOHOL LINALOOL, (+)- .BETA.-CITRONELLOL, (R)- FERRIC OXIDE YELLOW POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE COCO-CAPRYLATE/CAPRATE POLYGLYCERYL-3 OLEATE BETA CAROTENE ROSEMARY TOCOPHEROL ETHYLHEXYLGLYCERIN POLYHYDROXYSTEARIC ACID (2300 MW) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL SILICON DIOXIDE ZINC OXIDE ZINC OXIDE RMS SUPERNATURAL RADIANCE SERUM SPF 30 SUNSCREEN RICH AURA ZINC OXIDE ARTEMISIA VULGARIS TOP OIL MEDIUM-CHAIN TRIGLYCERIDES ISONONYL ISONONANOATE GLYCERIN DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE POTASSIUM SORBATE WATER PURSLANE SOYBEAN OIL LAVENDER OIL OLIVE OIL CHENOPODIUM QUINOA SEED PELARGONIUM GRAVEOLENS FLOWER OIL SODIUM BENZOATE SUNFLOWER OIL BUTYLENE GLYCOL BERGAMOT OIL PEA LUTEIN JUNIPERUS VIRGINIANA OIL COPAIFERA OFFICINALIS RESIN POLYGONUM CUSPIDATUM ROOT MAGNESIUM SULFATE, UNSPECIFIED CAPRYLYL GLYCOL NIACINAMIDE SQUALANE MICA TITANIUM DIOXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE MYRTLE LEAF OIL ROSA DAMASCENA FLOWER OIL LIMONENE, (+)- LINALOOL, (+)- .BETA.-CITRONELLOL, (R)- FERRIC OXIDE YELLOW POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE COCO-CAPRYLATE/CAPRATE POLYGLYCERYL-3 OLEATE PELARGONIUM CAPITATUM LEAF BETA CAROTENE ORANGE OIL GALBANUM OIL ROSEMARY TOCOPHEROL BENZYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL SILICON DIOXIDE ETHYLHEXYLGLYCERIN ZINC OXIDE ZINC OXIDE
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 Label Light Aura 1
Package Label Medium Aura 2
Package Label Rich Aura 3
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
Company Informataion dist. by: RMS Organics, LLC. Charleston, SC 29407 Made in USA with quality ingredients sourced from around the world. www.rmsbeauty.com
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.
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 from excessive heat and direct sun may stain fabrics
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.
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 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