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| Product NDC Code | 83249-016 | ||||
|---|---|---|---|---|---|
| Drug Name | Rms suncoverup super tint spf 50 toffee |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Rms organics 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 Zinc Oxide 12%
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 shake well. apply liberally 15 minutes before sun exposure reapply: at least every 2 hours for sun protection use a water resistant sunscreen 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 time 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, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Glycerin, Polyglyceryl-3 Polyricinoleate, Glyceryl Oleate, Methylpropanediol, Silica, Sodium Chloride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Diatomaceous Earth/Solum Diatomeae/Terra de diatomees, Lecithin, Ethylhexyl Palmitate, Ethylhexyl Stearate, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Phenylpropanol, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (non-GMO), Olea Europaea (Olive) Oil Unsaponifiables, Squalane (vegetable), Tetrasodium Glutamate Diacetate, Niacinamide, *Calendula Officinalis (Marigold) Flower Extract, *Curcuma Longa (Turmeric) Root Powder, *Equisetum Arvense (Horsetail) Leaf Extract, *Hemidesmus Indicus (Country Sarsaparilla) Root Powder, *Hypericum Perforatum (St. John's Wort) Flower Extract, Pisum Sativum (Pea) Seed Extract, *Withania Somnifera (Ashwagandha) Root Extract, *Glycyrrhiza Glabra (Licorice) Root, *Olea Europaea (Olive) Leaf Extract, Benzyl Alcohol, Chenopodium Quinoa Seed Extract, Potassium Sorbate, Sodium Benzoate, Sodium Hydroxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499). *Certified Organic
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 SUNCOVERUP SUPER TINT SPF 50 TAWNY Zinc Oxide POLYGLYCERYL-3 PENTARICINOLEATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE LECITHIN, SUNFLOWER SHEA BUTTER ETHYL ESTERS ETHYLHEXYL PALMITATE SQUALANE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES FERRIC OXIDE RED CALENDULA OFFICINALIS FLOWER HYPERICUM PERFORATUM FLOWER GLYCYRRHIZA GLABRA STEARALKONIUM HECTORITE MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE/CAPRATE METHYLPROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE TURMERIC SODIUM CHLORIDE LEVOMENOL SILICON DIOXIDE TOCOPHEROL POTASSIUM SORBATE DIATOMACEOUS EARTH FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE GLYCERIN WATER TETRASODIUM GLUTAMATE DIACETATE FERRIC OXIDE YELLOW EQUISETUM ARVENSE BRANCH HEMIDESMUS INDICUS ROOT WITHANIA SOMNIFERA ROOT OLEA EUROPAEA LEAF JOJOBA OIL CAPRYLYL GLYCOL ETHYLHEXYL STEARATE PHENYLPROPANOL NIACINAMIDE SODIUM HYDROXIDE BENZYL ALCOHOL TITANIUM DIOXIDE PEA CHENOPODIUM QUINOA SEED SODIUM BENZOATE RMS SUNCOVERUP SUPER TINT SPF 50 TAN Zinc Oxide POLYGLYCERYL-3 PENTARICINOLEATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE LECITHIN, SUNFLOWER SHEA BUTTER ETHYL ESTERS ETHYLHEXYL PALMITATE SQUALANE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES FERRIC OXIDE RED CALENDULA OFFICINALIS FLOWER HYPERICUM PERFORATUM FLOWER GLYCYRRHIZA GLABRA STEARALKONIUM HECTORITE MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE/CAPRATE METHYLPROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE TURMERIC SODIUM CHLORIDE LEVOMENOL SILICON DIOXIDE TOCOPHEROL POTASSIUM SORBATE DIATOMACEOUS EARTH FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE GLYCERIN WATER TETRASODIUM GLUTAMATE DIACETATE FERRIC OXIDE YELLOW EQUISETUM ARVENSE BRANCH HEMIDESMUS INDICUS ROOT WITHANIA SOMNIFERA ROOT OLEA EUROPAEA LEAF JOJOBA OIL CAPRYLYL GLYCOL ETHYLHEXYL STEARATE PHENYLPROPANOL NIACINAMIDE SODIUM HYDROXIDE BENZYL ALCOHOL TITANIUM DIOXIDE PEA CHENOPODIUM QUINOA SEED SODIUM BENZOATE RMS SUNCOVERUP SUPER TINT SPF 50 SAND Zinc Oxide POLYGLYCERYL-3 PENTARICINOLEATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE LECITHIN, SUNFLOWER SHEA BUTTER ETHYL ESTERS ETHYLHEXYL PALMITATE SQUALANE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES FERRIC OXIDE RED CALENDULA OFFICINALIS FLOWER HYPERICUM PERFORATUM FLOWER GLYCYRRHIZA GLABRA STEARALKONIUM HECTORITE MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE/CAPRATE METHYLPROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE TURMERIC SODIUM CHLORIDE LEVOMENOL SILICON DIOXIDE TOCOPHEROL POTASSIUM SORBATE DIATOMACEOUS EARTH FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE GLYCERIN WATER TETRASODIUM GLUTAMATE DIACETATE FERRIC OXIDE YELLOW EQUISETUM ARVENSE BRANCH HEMIDESMUS INDICUS ROOT WITHANIA SOMNIFERA ROOT OLEA EUROPAEA LEAF JOJOBA OIL CAPRYLYL GLYCOL ETHYLHEXYL STEARATE PHENYLPROPANOL NIACINAMIDE SODIUM HYDROXIDE BENZYL ALCOHOL TITANIUM DIOXIDE PEA CHENOPODIUM QUINOA SEED SODIUM BENZOATE RMS SUNCOVERUP SUPER TINT SPF 50 MOCHA Zinc Oxide POLYGLYCERYL-3 PENTARICINOLEATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE LECITHIN, SUNFLOWER SHEA BUTTER ETHYL ESTERS ETHYLHEXYL PALMITATE SQUALANE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES FERRIC OXIDE RED CALENDULA OFFICINALIS FLOWER HYPERICUM PERFORATUM FLOWER GLYCYRRHIZA GLABRA STEARALKONIUM HECTORITE MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE/CAPRATE METHYLPROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE TURMERIC SODIUM CHLORIDE LEVOMENOL SILICON DIOXIDE TOCOPHEROL POTASSIUM SORBATE DIATOMACEOUS EARTH FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE GLYCERIN WATER TETRASODIUM GLUTAMATE DIACETATE FERRIC OXIDE YELLOW EQUISETUM ARVENSE BRANCH HEMIDESMUS INDICUS ROOT WITHANIA SOMNIFERA ROOT OLEA EUROPAEA LEAF JOJOBA OIL CAPRYLYL GLYCOL ETHYLHEXYL STEARATE PHENYLPROPANOL NIACINAMIDE SODIUM HYDROXIDE BENZYL ALCOHOL TITANIUM DIOXIDE PEA CHENOPODIUM QUINOA SEED SODIUM BENZOATE RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY Zinc Oxide WATER TETRASODIUM GLUTAMATE DIACETATE FERRIC OXIDE YELLOW EQUISETUM ARVENSE BRANCH HEMIDESMUS INDICUS ROOT WITHANIA SOMNIFERA ROOT OLEA EUROPAEA LEAF CAPRYLYL GLYCOL ETHYLHEXYL STEARATE PHENYLPROPANOL JOJOBA OIL NIACINAMIDE BENZYL ALCOHOL TITANIUM DIOXIDE PEA CHENOPODIUM QUINOA SEED SODIUM BENZOATE SODIUM HYDROXIDE FERRIC OXIDE RED CALENDULA OFFICINALIS FLOWER HYPERICUM PERFORATUM FLOWER GLYCYRRHIZA GLABRA STEARALKONIUM HECTORITE POLYGLYCERYL-3 PENTARICINOLEATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE MEDIUM-CHAIN TRIGLYCERIDES LECITHIN, SUNFLOWER COCO-CAPRYLATE/CAPRATE METHYLPROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE TURMERIC SODIUM CHLORIDE LEVOMENOL SILICON DIOXIDE TOCOPHEROL POTASSIUM SORBATE DIATOMACEOUS EARTH FERROSOFERRIC OXIDE SHEA BUTTER ETHYL ESTERS ETHYLHEXYL PALMITATE SQUALANE ZINC OXIDE ZINC OXIDE GLYCERIN OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES RMS SUNCOVERUP SUPER TINT SPF 50 SPICE Zinc Oxide POLYGLYCERYL-3 PENTARICINOLEATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE LECITHIN, SUNFLOWER SHEA BUTTER ETHYL ESTERS ETHYLHEXYL PALMITATE SQUALANE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES FERRIC OXIDE RED CALENDULA OFFICINALIS FLOWER HYPERICUM PERFORATUM FLOWER GLYCYRRHIZA GLABRA STEARALKONIUM HECTORITE MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE/CAPRATE METHYLPROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE TURMERIC SODIUM CHLORIDE LEVOMENOL SILICON DIOXIDE TOCOPHEROL POTASSIUM SORBATE DIATOMACEOUS EARTH FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE GLYCERIN WATER TETRASODIUM GLUTAMATE DIACETATE FERRIC OXIDE YELLOW EQUISETUM ARVENSE BRANCH HEMIDESMUS INDICUS ROOT WITHANIA SOMNIFERA ROOT OLEA EUROPAEA LEAF JOJOBA OIL CAPRYLYL GLYCOL ETHYLHEXYL STEARATE PHENYLPROPANOL NIACINAMIDE SODIUM HYDROXIDE BENZYL ALCOHOL TITANIUM DIOXIDE PEA CHENOPODIUM QUINOA SEED SODIUM BENZOATE RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE Zinc Oxide POLYGLYCERYL-3 PENTARICINOLEATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE LECITHIN, SUNFLOWER SHEA BUTTER ETHYL ESTERS ETHYLHEXYL PALMITATE SQUALANE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES FERRIC OXIDE RED CALENDULA OFFICINALIS FLOWER HYPERICUM PERFORATUM FLOWER GLYCYRRHIZA GLABRA STEARALKONIUM HECTORITE MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE/CAPRATE METHYLPROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE TURMERIC SODIUM CHLORIDE LEVOMENOL SILICON DIOXIDE TOCOPHEROL POTASSIUM SORBATE DIATOMACEOUS EARTH FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE GLYCERIN WATER TETRASODIUM GLUTAMATE DIACETATE FERRIC OXIDE YELLOW EQUISETUM ARVENSE BRANCH HEMIDESMUS INDICUS ROOT WITHANIA SOMNIFERA ROOT OLEA EUROPAEA LEAF JOJOBA OIL CAPRYLYL GLYCOL ETHYLHEXYL STEARATE PHENYLPROPANOL NIACINAMIDE SODIUM HYDROXIDE BENZYL ALCOHOL TITANIUM DIOXIDE PEA CHENOPODIUM QUINOA SEED SODIUM BENZOATE
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.Product Packaging - Mahogany 1
Product Packaging - Mocha 1
Product Packaging - Sand 1
Product Packaging - Spice 1
Product Packaging - Tan 1
Product Packaging - Tawny 1
Product Packaging - Toffee 1
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 Information dist. by/par: RMS Organics, LLC Charleston, SC 29407 made in the 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 in this container 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