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| Product NDC Code | 84451-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Os-01 body spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | ONESKIN, 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 – Zinc Oxide 14 %
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 after 80 minutes of swimming or sweating. immediately after towel drying, at least every 2 hours 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: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.
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.OS-01 Body SPF 30 Zinc Oxide BIFIDOBACTERIUM ANIMALIS LACTIS CANDELILLA WAX CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE SHEANUT PHYTOSPHINGOSINE SODIUM BENZOATE PHENOXYETHANOL CAESALPINIA SPINOSA FRUIT POD SAFFLOWER OIL MEDIUM-CHAIN TRIGLYCERIDES POLYGLYCERYL-3 PENTARICINOLEATE BUTYLOCTYL SALICYLATE HELIANTHUS ANNUUS SEED WAX SODIUM LAUROYL LACTYLATE HELIANTHUS ANNUUS SPROUT ISOSTEARIC ACID LECITHIN, SOYBEAN STEARALKONIUM HECTORITE QUATERNIUM-90 BENTONITE CAMELLIA OIL ALOE VERA LEAF MALPIGHIA EMARGINATA SEED CERAMIDE NP CERAMIDE AP POLYHYDROXYSTEARIC ACID (2300 MW) CHOLESTEROL XANTHAN GUM CITRIC ACID MONOHYDRATE TRIETHYL CITRATE C13-15 ALKANE COCONUT ALKANES COCO-CAPRYLATE/CAPRATE HEXYLENE GLYCOL PROPYLENE GLYCOL PROPYLENE CARBONATE ETHYLHEXYLGLYCERIN CAPRYLYL GLYCOL WATER 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.Body SPF 30
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.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