FDA.reportPublic FDA data

Norwex Natural Sunscreen Broad Spectrum SPF 30

Manufacturer
Cosmetic Solutions LLC
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:20

Label at a glance#

ProductNorwex Natural Sunscreen Broad Spectrum SPF 30
Active ingredientZinc Oxide
Label structure7 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours or after 80 minutes of swimming or sweating and immediately after towel drying. For use on children under 6 months of age, consult doctor.

Label contents#

Full prescribing information#

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours or after 80 minutes of swimming or sweating and immediately after towel drying. For use on children under 6 months of age, consult doctor.

INDICATIONS & USAGE SECTION

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 15 or higher, limit time in the sun (especially from 10 a.m.-2 p.m.), and wear long-sleeved shirts, pants, hats, and sunglasses.

WARNINGS

WARNINGS SECTION

For external use only. Do not use on damaged/broken skin or if allergic to any of the ingredients. When using this product avoid contact with eyes. If contact occurs, rinse throughly with water. Stop use and consult a doctor if rash occurs.

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. Store at 15-30C. Do not use if safety seal is broken. May stain some fabrics.

OTC - ACTIVE INGREDIENT SECTION

MEDICINAL INGREDIENT MEDICINAL % W/W– P/P

OTC - PURPOSE SECTION

Zinc Oxide 20%

NON-MEDICINAL INGREDIENTS

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Tocopherols.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY : PLS (Taos,
New Mexico, USA) | DISTRIBUTED BY :
Norwex Canada, Inc., Dauphin, MB R7N 3B3

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURAL SUNSCREEN

EVERYDAY
30

Broad Spectrum SPF 30 (UVA/UVB)
Water Resistant (80 min)
Non-Nano
Dermatologist Tested

Norwex®

NPN 80091604

85 g / 3 oz. NET

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
PRINCIPAL DISPLAY PANEL - 85 g Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-1000-12025-01-30C16284748780-12cef2736-8dc9-d83d-e063-dadaa90ab31fNorwex ® Natural Sunscreen Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-1000-1Norwex Natural Sunscreen Broad Spectrum SPF 3085 g in 1 TUBEOINTMENT851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-1000NORWEX NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) OINTMENT [COSMETIC SOLUTIONS LLC]11 package rows20230120_69afde27-13cb-486c-9ecd-764db93f9dba.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
66163-100066163-1000-1

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
Zinc OxideSOI2LOH54ZACTIB
CASTOR OILD5340Y2I9GIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
OLIVE OIL6UYK2W1W1EIACT
SHEA BUTTERK49155WL9YIACT
WHITE WAX7G1J5DA97FIACT
SUNFLOWER OIL3W1JG795YIIACT

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
a63ebeff-416a-4ca1-9209-6c0a4865191069afde27-13cb-486c-9ecd-764db93f9dba2023-01-18WarningsExact identifier
spl id: a63ebeff-416a-4ca1-9209-6c0a48651910
spl set id: 69afde27-13cb-486c-9ecd-764db93f9dba

Reported adverse events (FAERS/openFDA)#

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