NENA Mineral Sunscreen SPF 30

Manufacturer
Ironwood Clay Company Inc.
Effective date
2025-04-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:58:51

Label at a glance#

ProductNENA Mineral Sunscreen SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn. Helps protect from sunburn. If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun. Sun Protection Factor 30 / SPF 30.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. 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 time in the sun, espec...

Label contents#

Full prescribing information#

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract
Aloe Barbadensis Leaf Juice
Alumina
Arachidyl Alcohol
Arachidyl Glucoside
Behenyl Alcohol
Benzyl Alcohol
Brassica Campestris/Aleurites Fordi Oil Copolymer
Calendula Officinalis Flower Extract
Camellia Sinensis Leaf Extract
Caprylic/Capric Triglyceride
Chromium Oxide Greens
Glycerin
Glyceryl Stearate SE
Helianthus Annuus (Sunflower) Seed Oil
Jojoba Esters
Myristyl Alcohol
Myristyl Glucoside
Propanediol
Salicylic Acid
Sea Silt
Sea Silt Extract
Sorbic Acid
Stearyl Alcohol,
Tocopherols
Tridecane
Undecane
Xanthan Gum

Warnings

WARNINGS SECTION

· 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.
· Stop use and ask a doctor if • rash occurs.
· Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally and evenly 15 minutes before sun exposure.
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 time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

Use a water resistant sunscreen if swimming or sweating.

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each dosage unit) Purpose

Titanium dioxide 2.3% ……………………………………………………………………… Sunscreen

Zinc oxide 22% .…………………….………………………………………………………. Sunscreen

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn.

Helps protect from sunburn.
If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun.
Sun Protection Factor 30 / SPF 30.

Questions?

OTC - QUESTIONS SECTION

Email contact@nenaskincare.com

Other information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

DOSAGE & ADMINISTRATION SECTION

Dosage: Cream

Route of adminstration: Topical

INDICATIONS & USAGE SECTION

See "Uses" and "Warnings"

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Refer to "Keep out of reach of children" in "Warnings" section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NENA Mineral Sunscreen SPF 30NENA Mineral Sunscreen SPF 30

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52311-686-01NENA Mineral Sunscreen SPF 301 in 1 BOXCREAM14
52311-686-01NENA Mineral Sunscreen SPF 3050 mL in 1 TUBECREAM504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52311-686NENA MINERAL SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [IRONWOOD CLAY COMPANY INC.]42 package rows20250410_18207a38-3901-e7d7-e063-6394a90a0890.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52311-68652311-686-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
325b6ed6-5be8-3ed9-e063-6294a90a9dbb18207a38-3901-e7d7-e063-6394a90a08902025-04-09WarningsExact identifier
spl id: 325b6ed6-5be8-3ed9-e063-6294a90a9dbb
spl set id: 18207a38-3901-e7d7-e063-6394a90a0890

Reported adverse events (FAERS/openFDA)#

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