SPF50 Premium Mineral Sunscreen Lotion

Manufacturer
Eden Brands Inc
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:31

Label at a glance#

ProductEvereden SPF50 Premium Mineral Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 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 15 minutes before sun exposure and as needed. • Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • 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 Broa...

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

PrimaryPrimary

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.7%, Zinc Oxide 14%

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.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes. Rinse with water to remove.

WARNINGS

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. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Shake well before use
• Apply liberally 15 minutes before sun exposure and
as needed.
• Reapply:
• After 40 minutes of swimming or sweating
• Immediately after towel drying
• 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), Caprylic/Capric Triglyceride, Dicaprylyl Ether, C13-15 Alkane, Propanediol, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Stearyl Citrate, Trioctyldodecyl Citrate, Tocopheryl Acetate, Sorbitan Sesquioleate, Polyglyceryl-10 Mono/Dioleate, Silica, Polyhydroxystearic Acid, Carthamus Tinctorius (Safflower) Oleosomes, Stearic Acid, Aluminum Hydroxide, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Cucumis Sativus (Cucumber) Fruit Extract, Caesalpinia Spinosa Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Vitis Vinifera (Grape) Seed Oil, Rosa Rubiginosa Seed Oil, Pongamia Pinnata Seed Extract, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Bisbolol, Sodium Phytate, Phenylpropanol, Caprylyl Glycol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SecondarySecondary

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72113-107-142023-03-15C16284748780-1e4f33bdf-afe6-d8a0-e053-dadaa90a6e4eSPF50 Premium Mineral Sunscreen Lotion
72113-107-142022-07-29C16284748780-1e4f33bdf-afe6-d8a0-e053-dadaa90a6e4eSPF50 Premium Mineral Sunscreen Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-107-14Evereden SPF50 Premium Mineral Sunscreen60 mL in 1 BOTTLE, DISPENSINGLOTION603
72113-107-14Evereden SPF50 Premium Mineral Sunscreen1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-107EVEREDEN SPF50 PREMIUM MINERAL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [EDEN BRANDS INC]3Legacy NDC, 2 package rows20231024_dcedc364-3cee-d30a-e053-2995a90a7d78.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72113-10772113-107-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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
082bf765-c945-3716-e063-6294a90a34dcdcedc364-3cee-d30a-e053-2995a90a7d782023-10-16WarningsExact identifier
spl id: 082bf765-c945-3716-e063-6294a90a34dc
spl set id: dcedc364-3cee-d30a-e053-2995a90a7d78

Reported adverse events (FAERS/openFDA)#

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