PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream 
Norwex Usa, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30

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

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:

Outer PackageInner Package

PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80971-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE28.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION68 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80971-102-011 in 1 CARTON01/01/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2023
Labeler - Norwex Usa, Inc. (016707931)

Revised: 7/2023
Document Id: 0152af37-33c9-8de5-e063-6294a90a9e1e
Set id: f527a8c5-b05e-5f3c-e053-2995a90aa1a3
Version: 5
Effective Time: 20230725
 
Norwex Usa, Inc.