FDA.reportPublic FDA data

Norwex Lip Glaze Broad Spectrum SPF 30

Manufacturer
Norwex Usa, Inc.
Effective date
2026-07-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:32:45

Label at a glance#

ProductNorwex Lip Glaze Broad Spectrum SPF 30 Rose
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply generously 15 minutes before sun exposure Children under 6 months of age:ask a doctor. reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating ​Sun Protection Measures ​Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measur...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged of broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

Stop use and ask

OTC - STOP USE SECTION

a doctor if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure
  • Children under 6 months of age:ask a doctor.
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • ​Sun Protection Measures ​Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 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 shiirts, pants, hats and sunglasses

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

diisostearyl malate, polybutene, hydrogenated polyisobutene, butyloctyl salicylate, microcrystalline wax/cire microcristalline, silica dimethyl silylate, caprylic/capric triglyceride, bis-diglyceryl polyacyladipate-2, sorbitan olivate, isononyl isononanoate, polyhydroxystearic acid, sorbitan isostearate, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, VP/hexadecene copolymer, flavor/aroma, menthone glycerin acetal, dehydroacetic acid, tocopherol, titanium dioxide/CI 77891, iron oxides/CI 77491, CI 77492, CI 77499

Questions?

OTC - QUESTIONS SECTION

Call 1-866-450-7499

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of cartonimage of primaryimage of primary

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80971-10480971-104-01, 80971-104-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SORBITAN OLIVATEMDL271E3GRIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ISOSTEARIC ACIDX33R8U0062IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
MENTHONE GLYCERIN ACETAL7QQ1EE6RCPIACT
DEHYDROACETIC ACID2KAG279R6RIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB

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
Norwex Lip Glaze Broad Spectrum SPF 30 RoseZINC OXIDENorwex Usa, Inc.565feded-8e25-e628-e063-6294a90aee482026-07-11WarningsExact identifier
ndc (package): 80971-104-02
ndc (package): 80971-104-01
ndc (product): 80971-104
ndc11 (package): 80971010402
ndc11 (package): 80971010401
spl id: 565feded-8e26-e628-e063-6294a90aee48
spl set id: 565feded-8e25-e628-e063-6294a90aee48

Reported adverse events (FAERS/openFDA)#

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