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| Product NDC Code | 30807-0003 | ||||
|---|---|---|---|---|---|
| Drug Name | Naked sundays broad spectrum sunscreen spf 50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | WILD CHILD LABORATORIES PTY LTD | ||||
| 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 Active Ingredients: Zinc Oxide 22.75 % Purpose Sunscreen
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 SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 3 years 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 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Inactive Ingredients: Ricinus Communis (Castor) Seed Oil, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Ceresin, Theobroma Cacao (Cocoa) Seed Butter, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Tocopheryl Acetate, Persea Gratissima (Avocado) Oil, Iron Oxides (CI 77492, CI 77491)
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 Use: Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin ageing 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.NAKED SUNDAYS BROAD SPECTRUM SUNSCREEN SPF 50 Zinc Oxide CERESIN THEOBROMA CACAO WHOLE POLYGLYCERYL-3 PENTARICINOLEATE C12-20 ALKYL BENZOATE ISOSTEARIC ACID AVOCADO OIL ZINC OXIDE ZINC OXIDE FERRIC OXIDE RED .ALPHA.-TOCOPHEROL ACETATE COCO-CAPRYLATE/CAPRATE CARNAUBA WAX CANDELILLA WAX RICINUS COMMUNIS SEED
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.Label 1
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. DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 3 years 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 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Questions: [email protected]
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.directions Directions: Apply generously 20 minutes before sun exposure. Reapply after 90 minutes, especially after swimming, exercising or towel drying. Reapply at least every 2 hours. 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 10AM - 2PM Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor.
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.Other Information: Protect this product from excess heat and direct sun. Store below 30°C / 86°F
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 Warnings: For external use only. Do not use on damaged or broken skin. Avoid prolonged sun exposure. If it gets in your eyes, wash well with water. Keep out of reach of children. Stop use and ask a doctor if rashes occur. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 3 years 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 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses
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