FDA.reportPublic FDA data

made of Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen

Manufacturer
MADEOF, LLC
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:07

Label at a glance#

Productmade of Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen
Active ingredientZINC OXIDE
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

Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect. Reapply: After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two hours. 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Uncoated Zinc Oxide 20.0%

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 - 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. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.

Reapply:

  • After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two hours.

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am-2pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • For children under six months of age ask a doctor.

Ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus* (Sunflower) Oil, Cocos Nucifera* (Coconut) Oil, Cera Alba* (Beeswax), Theobroma Cacao* (Cocoa) Seed Butter, Vanilla Oil* (Vanilla), Tocopherol*, Argania Spinosa Leaf* (Argan) Oil, Rubus Ideaus* (Raspberry) Seed Oil
*=Certified Organic

Other information:

SPL UNCLASSIFIED SECTION

Store at temperatures below 90°F

PRINCIPAL DISPLAY PANEL - 118 ml Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

made of ®
Broad Spectrum Sunscreen

SPF 30
Water Resistant (80 minutes)

79% Certified Organic Ingredients

21% Natural

NSF

Non GMO

Soy Free

Nut Free

Pediatrician Tested

Dermatologist Tested

4 fl.oz (118 ml)

Sunscreen boxSunscreen box

Sunscreen LabelSunscreen Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71439-050-162023-01-30C16284748780-1f386c649-c3a7-0266-e053-dadaa90a7c1amade of ® Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71439-050-16made of Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen1 in 1 CARTONLOTION12
71439-050-16made of Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen118 mL in 1 TUBELOTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71439-050MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN (ZINC OXIDE) LOTION [MADEOF, LLC]2Legacy NDC, 2 package rows20200118_5877736b-2953-56ce-e053-2991aa0a456e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71439-05071439-050-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
VANILLA PLANIFOLIA OIL0A3F415158IACT
ARGAN OIL4V59G5UW9XIACT
RASPBERRY SEED OIL9S8867952AIACT
TOCOPHEROLR0ZB2556P8IACT
COCOA BUTTER512OYT1CRRIACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
ZINC OXIDESOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT

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
9c592084-9431-c00b-e053-2a95a90a57905877736b-2953-56ce-e053-2991aa0a456e2020-01-17WarningsExact identifier
spl id: 9c592084-9431-c00b-e053-2a95a90a5790
spl set id: 5877736b-2953-56ce-e053-2991aa0a456e

Reported adverse events (FAERS/openFDA)#

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