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| Product NDC Code | 83580-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Everyday sun defense |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Hommerejuvenate, 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.Active Ingredient 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.- Apply generously 15 minutes before sun exposure - Reapply every 2 hours - Use a water-resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Ammonium Acryloyldimethyltaurate/VP Copolymer, Argania Spinosa Kernel Oil, Bisabolol, Butyrospermum Parkii (Shea Butter) Extract, C12-15 Alkyl Benzoate, C12-20 Glucoside, C14-22 Alcohol, Caprylyl/Capryl Glucoside, Cetearyl Alcohol, Coco Glucoside, Dimethicone, Ethyl Ferulate, Ethylhexylglycerin, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate, Phenoxyethanol, Phospholipids, Polyester-5, Propylene Glycol, Sodium Acryloyl Dimethyl Taurate Copolymer, Sorbitan Oleate Decylglucoside Crosspolymer, Squalane, Tocopheryl Acetate, Triethoxycaprylylsi-lane, Urea, Water
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.Indications & Usage Section High protection against sunburn
Purpose
Information about the drug product’s indications for use.OTC-Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Everyday Sun Defense Zinc Oxide ARGAN OIL ZINC OXIDE ZINC OXIDE ETHYL FERULATE PHENOXYETHANOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER SQUALANE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE TRIETHOXYCAPRYLYLSILANE WATER .ALPHA.-TOCOPHEROL ACETATE, D- SODIUM CHLORIDE ALPHA-TOCOPHEROL ACETATE GLYCERIN PROPYLENE GLYCOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) DIMETHICONE ALKYL (C12-15) BENZOATE CETOSTEARYL ALCOHOL COCO GLUCOSIDE C14-22 ALCOHOLS C12-20 ALKYL GLUCOSIDE ETHYLHEXYLGLYCERIN OMEGA-3 FATTY ACIDS GLUCONOLACTONE BENZYL ALCOHOL SODIUM BENZOATE SHEA BUTTER UREA SORBIC ACID POLYESTER-5 (TG-38) LEVOMENOL CHLORPHENESIN
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.Everyday Sun Defense
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.OTC-Ask Doctor Ask a doctor if rash occurs
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.OTC-Do Not Use 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.OTC-Keep Out of Reach of Children Keep out of reach of children. If swallowed, get medical help or contact Poison Control right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.OTC-Questions +1) 866-322-3010
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.OTC-Stop Use Stop use 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.OTC-When using 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.- 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 ask a doctor if rash occurs - Keep out of reach of children. If swallowed, get medical help or contact a Poison Control 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