FDA.reportPublic FDA data

Pro Formula

Manufacturer
Avasol LLC
Effective date
2023-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:50

Label at a glance#

ProductPro Formula
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

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

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

*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

OTHER SAFETY INFORMATION

  • protect package from moisture & extreme heat.

Principal Display Panel - 28 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58518-030-032025-01-30C16284748780-12cef2736-a6d6-d83d-e063-dadaa90ab31fDrug Facts
58518-030-042025-01-30C16284748780-12cef2736-a6d6-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58518-030-03Pro Formula28 g in 1 TUBESTICK281
58518-030-04Pro Formula224 g in 1 POUCHSTICK2241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58518-030PRO FORMULA (ZINC OXIDE, TITANIUM DIOXIDE) STICK [AVASOL LLC]12 package rows20230502_2c6eb04c-96e7-4fcf-a60e-2ffcf5fc8827.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58518-03058518-030-03, 58518-030-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
TAMANU OILJT3LVK84A1IACT
CANDELILLA WAXWL0328HX19IACT
THEOBROMA GRANDIFLORUM SEEDQ7RNT1G37VIACT
MICAV8A1AW0880IACT
TOCOPHEROLR0ZB2556P8IACT
FERROUS OXIDEG7036X8B5HIACT
PROPOLIS WAX6Y8XYV2NOFIACT
ALOE VERA LEAFZY81Z83H0XIACT
MANUKA OILM6QU9ZUH2XIACT
ROSEMARYIJ67X351P9IACT
CINNAMON BARK OILXE54U569ECIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b38abeca-fd41-42ec-a94e-3ec182c37f6b2c6eb04c-96e7-4fcf-a60e-2ffcf5fc88272023-04-24WarningsExact identifier
spl id: b38abeca-fd41-42ec-a94e-3ec182c37f6b
spl set id: 2c6eb04c-96e7-4fcf-a60e-2ffcf5fc8827

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.