FDA.reportPublic FDA data

NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut

Manufacturer
COSMAX USA
Effective date
2026-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:06

Label at a glance#

ProductNORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Uses Helps prevent sunburn

Dosage and administration

Directions 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 and sweating. 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 protec...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 13.90%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses

Helps prevent sunburn

WARNINGS SECTION

Warnings

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 - STOP USE SECTION

Stop use and ask 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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 and sweating.
  • 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:
  • Liimit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Microcrystalline Wax, 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, Iron Oxides (CI 77499), Menthone Glycerin Acetal, Dehydroacetic Acid, Tocopherol, Iron Oxides (CI 77491, CI 77499).

QUESTIONS

OTC - QUESTIONS SECTION

Questions?

Call 1-866-450-7499

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubeCartonCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-245-01NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut17 mg in 1 TUBEGEL171
68577-245-01NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut1 in 1 CARTONGEL11

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-24568577-245-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROSOFERRIC OXIDEXM0M87F357IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ZINC OXIDESOI2LOH54ZACTIB
DIISOSTEARYL MALATEQBS8A3XZGQIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MENTHONE GLYCERIN ACETAL7QQ1EE6RCPIACT
TOCOPHEROLR0ZB2556P8IACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
HYDROGENATED POLYISOBUTENE (450 MW)7YR4ZFS62EIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
SORBITAN OLIVATEMDL271E3GRIACT
FERRIC OXIDE RED1K09F3G675IACT
DEHYDROACETIC ACID2KAG279R6RIACT

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
57c5339d-4ace-ce7f-e063-6394a90a75a54c0437ef-b352-940e-e063-6394a90a36712026-07-29WarningsExact identifier
spl set id: 4c0437ef-b352-940e-e063-6394a90a3671

Reported adverse events (FAERS/openFDA)#

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