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| Product NDC Code | 79356-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Daily spf facial sunscreenlotion broad spectrum spf 32 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Onekind.25 | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Zinc Oxide 21%
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 generously 15 minutes before sun exposer. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun protection measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeved shirts, pants, hats and sunglasses. Other Information: 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 (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Helianthus annuus (sunflower) seed oil, Coco-Glucoside, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Glucoside , Xanthan Gum, Coco-Caprylate/Caprate, Lecithin, Caprylyl/Capryl Glucoside, Polyhydroxystearic Acid , Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Oryza Sativa Starch, Dipotassium Glycyrrhizate, Bisabolol, Caprylhydroxamic Acid, Sodium Pthalate, Sclerotium Gum, Sucrose, Phaeodactylum Tricornutum Extract, Glucose, Spirulina Maxima Extract, Tocopherol, C10 Alochol, C8 Alcohol.
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 Direction), 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.Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32 Zinc Oxide LEVOMENOL CAPRYLHYDROXAMIC ACID PHYTATE SODIUM BETASIZOFIRAN SUCROSE PHAEODACTYLUM TRICORNUTUM ANHYDROUS DEXTROSE SPIRULINA MAXIMA TOCOPHEROL C8-10 ALCOHOLS WATER MEDIUM-CHAIN TRIGLYCERIDES COCONUT ALKANES CETOSTEARYL ALCOHOL GLYCERIN ALOE VERA LEAF ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE COCO GLUCOSIDE SUNFLOWER OIL GLYCERYL MONOCAPRYLATE SHEA BUTTER CETEARYL GLUCOSIDE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE LECITHIN, SOYBEAN POLYGLYCERYL-3 RICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) COCO-CAPRYLATE/CAPRATE XANTHAN GUM STARCH, RICE ISOSTEARIC ACID GLYCYRRHIZINATE DIPOTASSIUM 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.Distributed by Onekind.25 Inc San Francisco, CA 94107 USA www.cocokind.com Image SPF32
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 the product in this container from excessive heat and direct sun.
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 products: 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.Warning: For external use only.
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