NORWEX PROTECT PREVENT MINERAL FACIAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide lotion

NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 by

Drug Labeling and Warnings

NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

ZInc Oxide 6.8%

Titanum Dioxide 2.88%

PURPOSE

Purpose

Sunscreen

USES

Uses

• helps prevent sunburn

Warnings

Warnings

For extenal use only

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs

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

Do not use on broken skin

DIRECTIONS

Directions

• apply generously 15 minutes before sun exposure
• reapply at least every 2 hours
• Reapply after 40 minutes of swimming or sweating
• Reapply immediately after towel drying.
• children under 6 months of age:Ask a doctor
• 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:

• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• Store in a cool dry place
• Do not use if safety seal is broken
• May stain some fabric.
• Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients:

Water, Isoamyl Laurate, Caprylic/ Capric Triglyceride, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Polyglyceryl-10 Laurate, Cetearyl Olivate, Lactobacillus Ferment, Sorbitan Olivate, Argania Spinosa (Argan) Kernel Oil, Fructose, Linum Usitatissimum (Flaxseed) Seed Oil*, Ribes Nigrum (Black Currant) Seed Oil*, Rubus Chamaemorus (Cloudberry) Seed Oil*, Withania Somnifera (Ashwagandha) Root Extract, Sambucus Nigra (Elderberry) Seed Oil*, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea (Lingonberry) Seed Oil*, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Betula Alba (Birch Sap Juice) Bark Extract, Ocimum Basilicum (Basil) Oil, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Hydroxy[1]acetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Poly[1]hydroxystearic Acid, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, Xanthan Gum, 1,2-Hexanediol, Citric Acid, Alumina, Microcrystalline Cellulose, Styrene/Acrylates Copolymer, Potassium Sorbate, Limonene, Linalool, Citral.

OTHER INFORMATION

Other information

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

QUESTIONS or COMMENTS

Questions or comments?

visit www.glossier.com or call toll-free
1-844-OK-GTEAM 1-844-654-8326

PRINCIPAL DISPLAY PANEL

PRIMARY PACKAGE

PRINCIPAL DISPLAY PANEL

Secondary Package

INGREDIENTS AND APPEARANCE

NORWEX PROTECT PREVENT MINERAL FACIAL SUNSCREEN BROAD SPECTRUM SPF30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.88 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.8 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM OXIDE (UNII: LMI26O6933)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
ORANGE OIL (UNII: AKN3KSD11B)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
WATER (UNII: 059QF0KO0R)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
FRUCTOSE (UNII: 6YSS42VSEV)
LINSEED OIL (UNII: 84XB4DV00W)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
RUBUS CHAMAEMORUS SEED OIL (UNII: WH495F04LZ)
SAMBUCUS NIGRA SEED OIL (UNII: ZZV3NWA4A3)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
LINGONBERRY SEED OIL (UNII: 44P1VFO6KM)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
BASIL OIL (UNII: Z129UMU8LE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
LEVOMENOL (UNII: 24WE03BX2T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-158-01	1 in 1 CARTON	09/01/2023
1		50 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	09/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-158)