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| Product NDC Code | 83286-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Daydream broad spectrum sunscreen spf 40 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Drmtlgy, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 17% w/v
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 to face and neck avoiding eye area 15 minutes before sun exposure. • reapply: • after 80 minutes of swimming or sweating immediately after towel drying • at least every 2 hours • 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 • children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Isododecane, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyhydroxystearic Acid, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Fructooligosaccharide, Glycoproteins, Bioflavonoids, Cyamopsis Tetragonoloba (Guar) Gum, Glycerin, Butyrospermum Parkii (Shea) Butter, 1,2-Hexanediol, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysorbate 20, Pentylene Glycol, Decyl Glucoside, Xanthan Gum
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.DAYDREAM Broad Spectrum Sunscreen SPF 40 Zinc Oxide ZINC OXIDE ZINC OXIDE WATER ISODODECANE PROPANEDIOL DIMETHICONE MEDIUM-CHAIN TRIGLYCERIDES POLYGLYCERYL-6 POLYRICINOLEATE POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE COCOYL CAPRYLOCAPRATE POLYGLYCERYL-10 DIOLEATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) POLYHYDROXYSTEARIC ACID (2300 MW) PHENYLSILANETRIOL LECITHIN, SOYBEAN DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SACCHARUM OFFICINARUM STEM FRUCTOOLIGOSACCHARIDES PLATELET GLYCOPROTEIN VI CITRUS BIOFLAVONOIDS GUAR GUM GLYCERIN SHEA BUTTER 1,2-HEXANEDIOL C18-36 ACID TRIGLYCERIDE TRIBEHENIN DISTEARDIMONIUM HECTORITE PROPYLENE CARBONATE AMINOMETHYLPROPANOL CAPRYLHYDROXAMIC ACID POLYSORBATE 20 PENTYLENE GLYCOL DECYL GLUCOSIDE XANTHAN GUM
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.Packaging DayDreamSunscreen-001
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
MEDICAL GRADE SKIN CARE UVA/UVB Protection 100% Mineral Filters Water & Sweat Resistant (80 Minutes) Oil-Free Vegan Paraben Free Sulfate Free Gluten Free Fragrance Free Never Tested On Animals Made in USA with globally sourced components. Distributed by: DRMTLGY, LLC Canoga Park, CA 91304 www.DRMTLGY.com
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.
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.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 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.
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