PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream

Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30 by

Drug Labeling and Warnings

Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Norwex Usa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVES/MEDICINAL INGREDIENTS:% W/W- P/P:

Titanium Dioxide ............ 2.88%
Zinc Oxide........................ 6.80%

PURPOSE

Sunscreen

USES

Helps prevent sunburn.

WARNINGS

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a doctor if

rash occurs.

Keep out of reach of children.

If swallowed, call a poison control centre or get medical help right away.

Do not use

on broken skin.

DIRECTIONS

• Apply liberally 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.; and 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.

NON-MEDICINAL/OTHER 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, Hydroxyacetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Polyhydroxystearic 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. *Organic Ingredients/ Ingrédients organiques.

Package Labeling:

INGREDIENTS AND APPEARANCE

PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80971-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	28.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	68 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ARGAN OIL (UNII: 4V59G5UW9X)
FRUCTOSE (UNII: 6YSS42VSEV)
FLAX SEED (UNII: 4110YT348C)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
RUBUS CHAMAEMORUS SEED OIL (UNII: WH495F04LZ)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
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)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80971-102-01	1 in 1 CARTON	01/01/2023
1		50 mL 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	01/01/2023

Labeler - Norwex Usa, Inc. (016707931)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(80971-102)