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| Product NDC Code | 73369-1201 | ||||
|---|---|---|---|---|---|
| Drug Name | Waxhead skin nourishing tinted sunscreen spf 31 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Kabana Skin Care | ||||
| 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 USP 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.apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply: after swimming or sweating immediately after towel drying 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 10 AM – 2 PM. 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 Spring water (aqua), Extra virgin olive oil* (oleo europaea fruit oil), Jojoba oil* (simmondsia chinensis seed oil), Vegetable glycerine#, Shea butter** (butyrospermum parkii seed oil), Vegetable emulsifying wax NF #, Vegetable Vitamin E # (tocopherol), Iron oxide *Certified Organic by USDA/NOP **Fair Trade Wildcrafted #Non-GMO
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, decreases risk of skin cancer and 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.Waxhead Skin Nourishing Tinted Sunscreen SPF 31 Sunscreen ALPHA-TOCOPHEROL WATER CETOSTEARYL ALCOHOL FERROSOFERRIC OXIDE POLYSORBATE 60 GLYCERIN SHEA BUTTER FERRIC OXIDE RED OLIVE OIL JOJOBA OIL ZINC OXIDE ZINC OXIDE FERRIC OXIDE YELLOW
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.Package Label Waxhead Tinted SPF 31 Label
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, or every 2 hours. Sun Protection Measures. Exposure to sun increases risk of skin cancer and skin aging. To decrease risk, regularly use sunscreen with broad spectrum SPF 15 or higher and other sun defense measures including: limit time in the sun, especially from 10 AM to 2 PM, wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months, ask a doctor.
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 the reach of children. If ingested, consult a Poison Control Center Immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Keep this product away excessive heat and direct sun. Shake before use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact Waxhead Sun Defense gowaxhead.com.
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. Keep product out of eyes. Rinse with water to remove. Do not use on damaged skin. Stop use and ask a doctor if rash develops.
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