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| Product NDC Code | 62742-4229 | ||||
|---|---|---|---|---|---|
| Drug Name | Oneskin os-01 shield broad spectrum spf 30 mineral sunscreen untinted |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Allure Labs | ||||
| 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 – Zinc Oxide 17.5 %
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.Direction- Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including: Limit time in the sun. especially from 10 am to 2 pm Wear long-sleeved shirts, pants hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water(aqua), Caprylic/Capric Triglyceride, Glycerin, Methyl Dihydroabietate, Cetearyl Alcohol, Cetyl Palmitate, Coco-Glucoside, Caprylyl/Capryl Glucoside, Sorbitan Palmitate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Nut Extract, Ethyl Ferulate, Bisabolol, Allantoin, Hydrolyzed Jojoba Esters, Acacia Senegal Gum, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Decapeptide-52*, Oryza Sativa (rice) Starch,Camellia Sinensis Leaf Extract, Euterpe Oleracea Fruit Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Sodium Phytate, Propylene Glycol, Phenoxyethanol, sodium Benzoate, Potassium Sorbate.
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 direction), 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.OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted Zinc Oxide GLYCERIN HELIANTHUS ANNUUS SPROUT XANTHAN GUM PHENOXYETHANOL ISOSTEARIC ACID CAPRYLYL/CAPRYL OLIGOGLUCOSIDE ALLANTOIN POLYHYDROXYSTEARIC ACID (2300 MW) TETRAHEXYLDECYL ASCORBATE STARCH, RICE MEDIUM-CHAIN TRIGLYCERIDES CETYL PALMITATE POLYGLYCERYL-3 PENTARICINOLEATE LECITHIN, SOYBEAN PHYTATE SODIUM ZINC OXIDE ZINC OXIDE SHEANUT LEVOMENOL HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) ACACIA ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL WATER SORBITAN MONOPALMITATE METHYL DIHYDROABIETATE CETOSTEARYL ALCOHOL SORBITAN OLIVATE .ALPHA.-TOCOPHEROL ACETATE PEPTIDE-T GREEN TEA LEAF COCO GLUCOSIDE ETHYL FERULATE SODIUM BENZOATE POTASSIUM SORBATE ACAI CAESALPINIA SPINOSA FRUIT POD CAPRYLYL GLYCOL PROPYLENE GLYCOL
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.OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted
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.
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 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 eye. 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.Warning – 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