NORWEX LIP GLAZE BROAD SPECTRUM SPF 30 HAZELNUT- zinc oxide gel

NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut by

Drug Labeling and Warnings

NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut by is a Otc medication manufactured, distributed, or labeled by COSMAX USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide 13.90%

PURPOSE

Purpose

Sunscreen

USES

Uses

Helps prevent sunburn

WARNINGS

Warnings

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 ask a doctor if rash occurs.

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control center right away.

DIRECTIONS

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 Information

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

INACTIVE INGREDIENT

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

Questions?

Call 1-866-450-7499

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NORWEX LIP GLAZE BROAD SPECTRUM SPF 30 HAZELNUT 
zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-245
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.9 g  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MENTHONE GLYCERIN ACETAL (UNII: 7QQ1EE6RCP)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-245-01	1 in 1 CARTON	03/06/2026
1		17 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/06/2026

Labeler - COSMAX USA (010990210)

Registrant - COSMAX USA (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA		010990210	manufacture(68577-245)