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| Product NDC Code | 78518-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | MONAT GLOBAL CORP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 18.8%
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 liberally 15 minutes before sun exposure Apply to sll skin exposed to the sun Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 10am-2pm wear a long-sleeved shirt, pants, hat, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Eau, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglceryl-3 Polyricinoleate, Oryza sativa (Rice) Bran Extract, Propanediol, Caprylic/Capric Triglyceride, Glyceryl Caprylate, Coco-caprylate/Caprate, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone, Cocos Nucifera (Coconut) Oil, Citrus Limon (Lemon) Peel Oil, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Tremella Fuciformis Sporocarp Extract, Camellia Sinensis Leaf Extract, Linoleic Acid, Lecithin, Limnanthes Alba (Meadowfoam) Seed Oil, Crambe Abyssinica Seed Oil, Camellia Oleifera Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil, Phytosteryl Canola Glycerides, Oleic Acid, Palmitic Acid, Stearic Acid, Triolein, Tocopherol, Adansonia Digitata Oil, Mauritia Flexuosa Fruit Oil, Gardenia Taitensis Flower Extract, Moringa Oleifera Seed Oil, Caryocar Brasiliense Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Tocopherol Acetate, Ulva Lactuca Extract, Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Triethyl Citrate, Glycerin, Betain, Glyceryl Undecylenate, Potassium Sorbate, Sodium Benzoate, Bentonite, May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).
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 If used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early skin aging caused by the sun.
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.Cream ZINC OXIDE LINOLEIC ACID LECITHIN, SUNFLOWER CITRUS AURANTIIFOLIA FRUIT OIL LIMNANTHES ALBA WHOLE CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL GLYCERYL CAPRYLATE WATER DODECANE POLYGLYCERYL-3 DIISOSTEARATE DIMETHICONE COCOS NUCIFERA WHOLE CITRUS LIMON SEED OIL ALPHA-TOCOPHEROL ACETATE HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) COCO-CAPRYLATE DILINOLEIC ACID/BUTANEDIOL COPOLYMER ULVA LACTUCA POLYGLYCERYL-6 POLYRICINOLEATE SILICON DIOXIDE CITRUS AURANTIUM FRUIT OIL TREMELLA FUCIFORMIS WHOLE CAMELLIA SINENSIS WHOLE OLEIC ACID STEARIC ACID GLYCERYL TRIOLEATE PHYTOSTERYL MACADAMIATE TOCOPHEROL CARYOCAR BRASILIENSE FRUIT OIL TRIHEPTANOIN SOLANUM LYCOPERSICUM DAUCUS CAROTA SUBSP. SATIVUS SEED MAURITIA FLEXUOSA FRUIT OIL MORINGA OLEIFERA SEED OIL HELIANTHUS ANNUUS WHOLE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES BRASSICA NAPUS WHOLE COCONUT ALKANES POLYGLYCERYL-5 POLYRICINOLEATE PROPANEDIOL FERRIC OXIDE YELLOW SIMMONDSIA CHINENSIS SEED ORYZA SATIVA WHOLE MEDIUM-CHAIN TRIGLYCERIDES CAMELLIA OLEIFERA SEED PALMITIC ACID ADANSONIA DIGITATA SEED OIL GARDENIA TAITENSIS FLOWER CASTOR OIL TRIETHYL CITRATE GLYCERIN GLYCERYL 1-UNDECYLENATE SODIUM BENZOATE BENTONITE TITANIUM DIOXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE COCO-CAPRYLATE/CAPRATE POLYHYDROXYSTEARIC ACID (2300 MW) MAGNESIUM SULFATE, UNSPECIFIED FORM BETAINE POTASSIUM SORBATE TRICAPRYLIN ZINC OXIDE ZINC OXIDE
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 NDC 78518-005 Primary Package
Outer Package 78518-005-01- Outer Outer package Cedar
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 damage or 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 product is swallowed, get medical help or contact a poison control center 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 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect the product in this container from excessive heat and direct sun.
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.For external use only Do not use on damage or broken skin 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 product is swallowed, get medical help or contact a poison control center right away.
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