Ultra sheer mineral sunscreen PRO SPF30

Manufacturer
Eden Brands Inc.
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:20

Label at a glance#

ProductUltra sheer mineral sunscreen PRO SPF30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

• Shake well before use. • Apply liberally to face and body 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months of age: ask a doctor. • 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 ...

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

SPF 30 PRO PrimarySPF 30 PRO Primary

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.8%

PURPOSE:

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

• 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.

WARNINGS:

WARNINGS SECTION

• For external use only

OTC - DO NOT USE SECTION

• Do not use on damaged or broken skin.

OTC - STOP USE SECTION

• Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Shake well before use.

• Apply liberally to face and body 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating.

• Reapply at least every 2 hours.

• Children under 6 months of age: ask a doctor.

• 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 your time in the sun, especially from 10 a.m. – 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water (Aqua), Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Squalane, C13-15 Alkane, Polyglyceryl-4 Laurate, Hydroxyapatite, Persea Gratissima (Avocado) Oil, Polyglyceryl-6 Laurate, Isoamyl Laurate, Propanediol, Polyhydroxystearic Acid, 1,2-Hexanediol, Carthamus Tinctorius (Safflower) Oleosomes, Sodium Citrate, Citric Acid, Glyceryl Citrate/Lactate/Linoleate/Oleate, Maris Limus Extract, Sclerotium Gum, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Glycine Soja (Soybean) Seed Extract, Magnolia Officinalis Bark Extract, Chondrus Crispus Extract, Pongamia Pinnata Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Glabra Seed Oil, Trisodium Ethylenediamine Disuccinate, Chimyl Alcohol, Tasmannia Lanceolata Leaf Extract, Hydroxyacetophenone, Sorbitan Isostearate, Phenylpropanol, Caprylyl Glycol, Tocopherol, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Sodium Hyaluronate, Naringin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30 PRO SecondarySPF 30 PRO Secondary

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-112-14Ultra sheer mineral sunscreen PRO SPF301 in 1 CARTONLOTION11
72113-112-14Ultra sheer mineral sunscreen PRO SPF3060 g in 1 BOTTLELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-112ULTRA SHEER MINERAL SUNSCREEN PRO SPF30 (ZINC OXIDE) LOTION [EDEN BRANDS INC.]1Current NDC, 2 package rows20250216_2ce06566-2eb0-9a00-e063-6394a90a9ba9.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72113-11272113-112-14

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 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
Ultra sheer mineral sunscreen PRO SPF30ZINC OXIDEEden Brands Inc.2ce06566-2eb0-9a00-e063-6394a90a9ba92025-02-14WarningsExact identifier
ndc (package): 72113-112-14
ndc (product): 72113-112
ndc11 (package): 72113011214
spl id: 2ce06566-2eb1-9a00-e063-6394a90a9ba9
spl set id: 2ce06566-2eb0-9a00-e063-6394a90a9ba9

Reported adverse events (FAERS/openFDA)#

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