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| Product NDC Code | 68577-158 | ||||
|---|---|---|---|---|---|
| Drug Name | Norwex protect prevent mineral facial sunscreen broad spectrum spf30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | COSMAX USA, CORPORATION | ||||
| 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.Active Ingredients ZInc Oxide 6.8% Titanum Dioxide 2.88%
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 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
A list of inactive, non-medicinal ingredients in a drug product.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.
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 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.NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 Titanium Dioxide, Zinc Oxide LEMON OIL POLYHYDROXYSTEARIC ACID (2300 MW) DOCOSANOL CETYL ALCOHOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) 1,2-HEXANEDIOL ALUMINUM OXIDE LIMONENE, (+/-)- LINALOOL, (+/-)- CITRAL ORANGE OIL HYDROXYPHENYL PROPAMIDOBENZOIC ACID WATER ISOAMYL LAURATE MEDIUM-CHAIN TRIGLYCERIDES BUTYLOCTYL SALICYLATE GLYCERIN ALKYL (C12-15) BENZOATE ARACHIDYL ALCOHOL POLYGLYCERYL-10 LAURATE CETEARYL OLIVATE LIMOSILACTOBACILLUS FERMENTUM SORBITAN OLIVATE ARGANIA SPINOSA SEED FRUCTOSE LINSEED OIL RIBES NIGRUM SEED OIL RUBUS CHAMAEMORUS SEED OIL 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 TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE POTASSIUM SORBATE STEARIC ACID XANTHAN GUM CELLULOSE, MICROCRYSTALLINE BERGAMOT OIL HYDROXYACETOPHENONE BIOSACCHARIDE GUM-4 LEVOMENOL ARACHIDYL GLUCOSIDE STEARYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID
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.PRIMARY PACKAGE Inner package
Secondary Package Outer Carton
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, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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
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 ask 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 keep out of eyes. Rinse with water to remove.
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 Warnings For extenal use only When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash 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
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