NORWEX NATURAL SUNSCREEN LIP BALM BROAD SPECTRUM SPF 15- zinc oxide stick

Norwex Natural Sunscreen Lip Balm Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Norwex Natural Sunscreen Lip Balm Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 10.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

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 consult a doctor if a rash occurs.

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

• 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

Protect the product from excessive heat and direct sun.

Other Ingredients

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

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

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

INGREDIENTS AND APPEARANCE

NORWEX NATURAL SUNSCREEN LIP BALM BROAD SPECTRUM SPF 15 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	10.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TAMANU OIL (UNII: JT3LVK84A1)
RASPBERRY SEED OIL (UNII: 9S8867952A)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-1001-1	4.2 g in 1 CYLINDER; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2019

Labeler - Cosmetic Solutions LLC (807907928)