NORWEX NATURAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide ointment

Norwex Natural Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Norwex Natural Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIRECTIONS

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours or after 80 minutes of swimming or sweating and immediately after towel drying. For use on children under 6 months of age, consult doctor.

INDICATIONS & USAGE

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 broad spectrum SPF 15 or higher, limit time in the sun (especially from 10 a.m.-2 p.m.), and wear long-sleeved shirts, pants, hats, and sunglasses.

WARNINGS

For external use only. Do not use on damaged/broken skin or if allergic to any of the ingredients. When using this product avoid contact with eyes. If contact occurs, rinse throughly with water. Stop use and consult a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Store at 15-30C. Do not use if safety seal is broken. May stain some fabrics.

ACTIVE INGREDIENT

MEDICINAL INGREDIENT MEDICINAL % W/W– P/P

Zinc Oxide 20%

NON-MEDICINAL INGREDIENTS

Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Tocopherols.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY : PLS (Taos,
New Mexico, USA) | DISTRIBUTED BY :
Norwex Canada, Inc., Dauphin, MB R7N 3B3

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

NATURAL SUNSCREEN

EVERYDAY
30

Broad Spectrum SPF 30 (UVA/UVB)
Water Resistant (80 min)
Non-Nano
Dermatologist Tested

Norwex®

NPN 80091604

85 g / 3 oz. NET

INGREDIENTS AND APPEARANCE

NORWEX NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
SHEA BUTTER (UNII: K49155WL9Y)
WHITE WAX (UNII: 7G1J5DA97F)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-1000-1	85 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2019

Labeler - Cosmetic Solutions LLC (807907928)