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| Product NDC Code | 82657-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Cay skin mobay mineral sunscreen drops spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Cay Skin, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Zinc Oxide 9.4%
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 Adults and children over 6 months of age: Apply liberally 15 minutes before sun exposure Reapply: at least every 2 hours; immediately after towel drying Use a water resistant sunscreen if swimming or sweating. 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 protections measures including: limit time in the sun, especially from 10 a.m. - 2 p.m.; wear long-sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Water, Eau), C12-15 Alkyl Benzoate, Sorbitan Oleate Decylglucoside Crosspolymer, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glycerin, Polyester-5, Aloe Barbadensis Leaf Juice, Psidium Guajava Leaf Extract, Ethyl Ferulate, Squalane, Butyrospermum Parkii (Shea Butter) Extract, Bisabolol, Phospholipids, Tocopherol, Urea, Chondrus Crispus Extract, Dimethicone, Ethylhexylglycerin, Lactobacillus Ferment, Gluconolactone, Propanediol, 1,2 Hexanediol, Triethoxycaprylylsilane, Hydroxyacetophenone, Phenoxyethanol, Sodium Chloride, Benzyl Alcohol, Sodium Benzoate, Chlorphenesin, Sorbic Acid, Potassium Sorbate, Citric Acid, Caramel
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.Cay Skin MoBay Mineral Sunscreen Drops SPF 30 Zinc Oxide C12-15 ALKYL BENZOATE SORBITAN OLEATE DECYLGLUCOSIDE CROSSPOLYMER AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ETHYL FERULATE BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT UREA DIMETHICONE CHLORPHENESIN SORBIC ACID CARAMEL GLYCERIN ALOE VERA LEAF SQUALANE ETHYLHEXYLGLYCERIN PROPANEDIOL TRIETHOXYCAPRYLYLSILANE POTASSIUM SORBATE ALPHA-TOCOPHEROL ACETATE GLUCONOLACTONE SODIUM CHLORIDE CITRIC ACID MONOHYDRATE 1,2-HEXANEDIOL HYDROXYACETOPHENONE PSIDIUM GUAJAVA LEAF CHONDRUS CRISPUS BENZYL ALCOHOL ZINC OXIDE ZINC OXIDE WATER ARGAN OIL BISABOLOL OMEGA-3 FATTY ACIDS TOCOPHEROL PHENOXYETHANOL SODIUM BENZOATE
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.Product Labeling 1
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
Company Information DISTRIBUTED BY CAY SKIN, INC., MIAMI, FL 33179 CAYSKIN.COM
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 damaged 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect this product from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? cayskin.com 1-833-606-1131
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 skin 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 For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and consult a doctor if skin 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