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| Product NDC Code | 58518-030 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pro formula |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | STICK | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Avasol LLC | ||||||
| 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 (non-nano, Uncoated) 24.5% Titanium Dioxide (non-nano, Uncoated) 6%
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 apply liberally before sun reapply: after 80 min. of swimming or sweating, immediately after towel drying, or as needed children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients * Caprylic/Capric Triglyceride (Coconut), *Cocos Nucifera (Coconut) Oil,*Helianthus annuus (Sunflower) Oil, **Euphorbia cerifera (Candelilla) wax, *Calophyllum Inophyllum (Tamanu)Oil,*Beeswax,**Theobroma Grandiflorum (Cupuacu) Seed Butter, Mica, Tocopherol (Vitamin E),*Aloe Vera Leaf, Iron oxides, *Propolis, *Rosmarinus Officinalis (Rosemary) Leaf Extract, **Leptospermum scoparium (Manuka) Oil,*Cinnamomum Zeylanicum(Cinnamon) Bark Oil. *Organic **Wildcrafted
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
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Pro Formula ZINC OXIDE, TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES COCONUT OIL SUNFLOWER OIL YELLOW WAX TAMANU OIL CANDELILLA WAX THEOBROMA GRANDIFLORUM SEED MICA TOCOPHEROL FERROUS OXIDE PROPOLIS WAX ALOE VERA LEAF MANUKA OIL ROSEMARY CINNAMON BARK 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.Principal Display Panel - 28 g Tube Label avasol ® mineral sunscreen PRO 50+SPF Net Wt 1 oz (28 g) Pro-Grade Skin Barrier Water-resistant (80 min.) Broad Spectrum (UVA/UVB) Safer for People & the Ocean USDA Certified 100% Biobased Principal Display Panel - 28 g Tube Label
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 if allergic to ingredients, or nuts. Test small area first.
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 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 package from moisture & extreme heat.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? visit www.avasol.com
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.
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 out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs. Do not use if allergic to ingredients, or nuts. Test small area first. Keep out of reach of children. If swallowed, get medical help 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