FDA.reportPublic FDA data

Norwex Natural Sunscreen Lip Balm Broad Spectrum SPF 15

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 Lip Balm Broad Spectrum SPF 15
Active ingredientZinc Oxide
Label structure11 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Sun Protection Measures: Use Broad Spectrum sunscreens with SPF values of 15 or higher regularly and as directed. Limit time in the sun (especially between 10 a.m. to 2 p.m.) when the sun's rays are most intense. Wear clothing like long-sleeved shirts, pants, sunglasses and broad-brim...

Storage and handling

Protect the product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

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 consult a doctor if a rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact poison control center or get medical help immediately. Consult a health care professional before applying sunscreen to infants younger than 6 months.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating and immediately after towel drying.

Sun Protection Measures: Use Broad Spectrum sunscreens with SPF values of 15 or higher regularly and as directed.

  • Limit time in the sun (especially between 10 a.m. to 2 p.m.) when the sun's rays are most intense.
  • Wear clothing like long-sleeved shirts, pants, sunglasses and broad-brimmed hats to cover skin exposed to the sun.

Other Information

STORAGE AND HANDLING SECTION

Protect the product from excessive heat and direct sun.

Other Ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil, Beeswax, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor, Polyhydroxystearic Acid, Butyrospermum Parkii (Shea) Butter, Rubus Idaeus (Raspberry) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil, Calophyllum Inophyllum Seed Oil

Questions or Comments

OTC - QUESTIONS SECTION

Visit www.Norwex.com or call toll free 1-866-450-7499.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY: PLS (Taos, New Mexico, USA) | DISTRIBUTED BY: Norwex USA Inc., Coppell, TX, 75019

PRINCIPAL DISPLAY PANEL - 4.3 g Cylinder Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURAL
SUNSCREEN
LIP BALM

EVERYDAY
15

Broad Spectrum SPF 15
(UVA/UVB)
Water Resistant (80 min)

Sealed for your protection

4.3 g /
0.15 oz.
NET WT

Principal Display Panel - 4.3 g Cylinder Label
Principal Display Panel - 4.3 g Cylinder Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-1001-12025-01-30C16284748780-12cef2736-92ec-d83d-e063-dadaa90ab31fNorwex Natural Sunscreen Lip Balm Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-1001-1Norwex Natural Sunscreen Lip Balm Broad Spectrum SPF 154.2 g in 1 CYLINDERSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-1001NORWEX NATURAL SUNSCREEN LIP BALM BROAD SPECTRUM SPF 15 (ZINC OXIDE) STICK [COSMETIC SOLUTIONS LLC]11 package rows20230120_3b21b187-da30-4e64-a85b-c8991591e72c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-100166163-1001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
COCOA BUTTER512OYT1CRRIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHEA BUTTERK49155WL9YIACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
TAMANU OILJT3LVK84A1IACT
RASPBERRY SEED OIL9S8867952AIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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
86517050-3aa0-4ee7-b0d7-fca0375444333b21b187-da30-4e64-a85b-c8991591e72c2023-01-18WarningsExact identifier
spl id: 86517050-3aa0-4ee7-b0d7-fca037544433
spl set id: 3b21b187-da30-4e64-a85b-c8991591e72c

Reported adverse events (FAERS/openFDA)#

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