Premium Mineral Sunscreen Broad Spectrum SPF 30

Manufacturer
Eden Brands | Baxter Laboratories Pty. Ltd.
Effective date
2018-02-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:33

Label at a glance#

ProductPremium Mineral Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Zinc Oxide 22% Sunscreen

OTC - PURPOSE SECTION

Uses

  • Helps prevent Sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

Warnings:

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • after 80 minutes of swimming or sweating
    • Immediately after towel drying
    • at least every two hours
    • Children under 6 months of age: ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of 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 your time in the sun, especially from 10a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Caprylic/Capric Triglyceride, Vitis Vinifera (grape) Seed Extract, Butyrospermum Parkii (shea) Butter, Silica, Aluminum Starch Octenylsuccinate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera, Beeswax/Cera Alba, Glyceryl Isostearate, Brassica Campestris/Aleurites Fordii Oil Copolymer, Polyhydroxystearic Acid, Simmondsia Chinensis (jojoba) Seed Oil, Tocopherol, Carthamus Tinctorious (Safflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Water/Aqua, Camelilla sinensis leaf Extract, Rosa Canina Fruit Oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30 Premium Mineral Sunsreen

High Protection

Broad Spectrum SPF 30

Water resistant (80 minutes)

Mineral based Active Ingredient

Net Wt. 3.0oz / 85 g

boxbox

PrimaryPrimary

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72113-101-012020-01-31C16284748780-19d75b9d0-6907-f424-e053-dadaa90a57cePremium Mineral Sunscreen Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-101-01Premium Mineral Sunscreen Broad Spectrum SPF 3085 g in 1 BOXLOTION851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-101PREMIUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [EDEN BRANDS]1Legacy NDC, 1 package rows20180214_650a1595-a017-b221-e053-2991aa0a98d5.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72113-10172113-101-01

Ingredients#

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

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

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
650a1595-a018-b221-e053-2991aa0a98d5650a1595-a017-b221-e053-2991aa0a98d52018-02-12WarningsExact identifier
spl id: 650a1595-a018-b221-e053-2991aa0a98d5
spl set id: 650a1595-a017-b221-e053-2991aa0a98d5

Reported adverse events (FAERS/openFDA)#

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