Pro Formula
FDA Label NDC 58518-030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avasol Llc for the product Pro Formula (NDC 58518-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Purpose

Sunscreen

Sunscreen

Uses

  • helps prevent sunburn

Warnings

  • For external use only.
  • Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash or irritation occurs.

Otc - Do Not Use

Do not use if allergic to ingredients, or nuts. Test small area first.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help right away.

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 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

Other Information

  • protect package from moisture & extreme heat.

Questions?

visit www.avasol.com

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)

Principal Display Panel (28 g Tube Label)

* Please review the disclaimer below.