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| Product NDC Code | 81486-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Wotnot naturals natural sunscreen spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | ECOdirect Pty Ltd (Trading as Wotnot Naturals) | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 25%
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 before use and apply liberally 15 minutes before sun exposure. Reapply regularly, at least every 2 hours, after swimming, towelling dry or perspiring. Use a water resistant sunscreen if swimming or perspiring. Children under 6 months: 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially 10am-2pm. Wear long-sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients vitis vinifera (grape) seed oil, simmondsia chinensis (jojoba) seed oil, carthamus tinctorius (safflower) oil, olea europaea (olive) fruit oil, cera alba (beeswax), silica, butyrospermum parkii (shea butter), purified water, fragrance (natural), aloe barbadensis (aloe vera) extract, tocopherol (vitamin e), euphorbia cerifera (candelilla) wax, copernicia prunifera (carnauba) wax.
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.Use Helps prevent sunburn. If used as directed with other sun protection measures ( see Directions ) decreases the risk of skin cancer and early skin aging caused by 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.Wotnot Naturals Natural Sunscreen SPF 30 ZINC OXIDE TOCOPHEROL JOJOBA OIL CARNAUBA WAX CANDELILLA WAX GRAPE SEED OIL ZINC OXIDE ZINC OXIDE SILICON DIOXIDE WATER OLIVE OIL YELLOW WAX SHEA BUTTER ALOE VERA LEAF SAFFLOWER OIL
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 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 Wotnot Naturals Pty Ltd, 5/19 Rodborough Road, Frenchs Forest, NSW 2086, Australia
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 Centre 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 product from excessive heat and direct sun. Report serious adverse reactions to: Report Reaction, PO Box 22, Plainsboro, New Jersey 08536
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? Email: [email protected]
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 or irritation 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. Stop use and ask a doctor if rash or irritation occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed get medical help, or contact a Poison Control Centre 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