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| Product NDC Code | 80971-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Protect prevent daily mineral sunscreen broad spectrum spf30 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Norwex Usa, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVES/MEDICINAL INGREDIENTS:% W/W- P/P: Titanium Dioxide ............ 2.88% Zinc Oxide........................ 6.80% PURPOSE Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.PURPOSE Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE WATER ISOAMYL LAURATE MEDIUM-CHAIN TRIGLYCERIDES BUTYLOCTYL SALICYLATE GLYCERIN ALKYL (C12-15) BENZOATE ARACHIDYL ALCOHOL POLYGLYCERYL-10 LAURATE CETEARYL OLIVATE SORBITAN OLIVATE ARGAN OIL FRUCTOSE FLAX SEED RIBES NIGRUM SEED OIL RUBUS CHAMAEMORUS SEED OIL WITHANIA SOMNIFERA ROOT SAMBUCUS NIGRA SEED OIL GLYCYRRHIZINATE DIPOTASSIUM LINGONBERRY SEED OIL HIPPOPHAE RHAMNOIDES FRUIT BETULA PUBESCENS BARK BASIL OIL .ALPHA.-TOCOPHEROL ACETATE LAVENDER OIL PELARGONIUM GRAVEOLENS FLOWER OIL BERGAMOT OIL ORANGE OIL, COLD PRESSED LEMON OIL, COLD PRESSED HYDROXYACETOPHENONE BIOSACCHARIDE GUM-4 STEARIC ACID LEVOMENOL ARACHIDYL GLUCOSIDE DOCOSANOL CETYL ALCOHOL STEARYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED XANTHAN GUM 1,2-HEXANEDIOL CITRIC ACID MONOHYDRATE ALUMINUM OXIDE MICROCRYSTALLINE CELLULOSE POTASSIUM SORBATE LIMONENE, (+)- LINALOOL, (+/-)- CITRAL TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Labeling: Outer Package Inner Package
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult a doctor if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API