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| Product NDC Code | 81568-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Dr. brandt sun shield spf 50 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M020 | ||||
| Labeler Name | Dr. Brandt | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 17%
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 and evenly 15 minutes before sun exposure • 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 protection measures including • Limit time in the sun, especially from 10 a.m.-2 p.m. • Wear long-sleeved shirts, pants, hats and sunglasses. • Reapply at least 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 Ingredients Water, Isododecane, Polyglyceryl-6 Polyricinoleate, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Trimethylsiloxysilicate, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Isoamyl Laurate, Neopentyl Glycol Diheptanoate, Polyglyceryl-10 Dioleate, Lecithin, Polyhydroxystearic Acid, Ectoin, Polymethylsilsesquioxane, Polysilicone-11, Disteardimonium Hectorite, Butyrospermum Parkii (Shea) Butter, Glycerin, Phenoxyethanol, Propylene Carbonate, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethylhexylglycerin, Polysorbate 20, Sclareolide, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Linalool, Linalyl Acetate, Plankton Extract, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Decyl Glucoside, Sodium Ascorbate, Caprylyl Glycol, Hexylene Glycol, Tocopherol.
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.dr. brandt SUN SHIELD SPF 50 Zinc Oxide ZINC OXIDE ZINC CATION WATER ISODODECANE POLYGLYCERYL-6 POLYRICINOLEATE PROPANEDIOL DIMETHICONE, UNSPECIFIED MEDIUM-CHAIN TRIGLYCERIDES TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) BUTYLOCTYL SALICYLATE COCOYL CAPRYLOCAPRATE ISOAMYL LAURATE NEOPENTYL GLYCOL DIHEPTANOATE POLYGLYCERYL-10 DIOLEATE SOYBEAN LECITHIN POLYHYDROXYSTEARIC ACID (2300 MW) ECTOINE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) DISTEARDIMONIUM HECTORITE SHEA BUTTER GLYCERIN PHENOXYETHANOL PROPYLENE CARBONATE AMINOMETHYLPROPANOL ORANGE OIL, COLD PRESSED ETHYLHEXYLGLYCERIN POLYSORBATE 20 SCLAREOLIDE .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) DIMETHICONOL (600000 CST) LINALOOL, (+/-)- LINALYL ACETATE CHLORELLA VULGARIS LAVENDER OIL LAVANDIN OIL DECYL GLUCOSIDE SODIUM ASCORBATE CAPRYLYL GLYCOL HEXYLENE GLYCOL TOCOPHEROL
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 SunShield-101 SunShield-101
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
INTEGRATIVE DERMATOLOGY SPF 50 UVA/UVB PROTECTION BROAD SPECTRUM BRIGHT THIS WAY 100% MINERAL SUNSCREEN NON-NANO ZINC OXIDE + ECTOIN + PLANKTON EXTRACT COMPLEX + CLARY SAGE FERMENT LIQUID SUN SHIELD TM Protect - Brighten - Moisturize This lightweight, 100% mineral sunscreen formulated with non-nano zinc oxide and brightening agents not only defends against UVA/UVB rays with an SPF 50 but also features extremolyte technology which helps protect skin from HEV/blue light from devices, infrared radiation, and pollution. Clary Sage and Plankton extract help protect against hyperpigmentation, reduce the look of existing age spots and even skin tone for a brighter, more youthful looking appearance. DIRECTIONS: Shake well before use. Apply daily to face, neck and chest, as the last step in your skincare routine. CAUTION: For external use only. Keep out of reach of children. Avoid contact with eyes. Apply sunscreen before you go out in the sun. Repeat the application frequently to maintain the protection, especially after sweating, swimming or wiping yourself. Do not stay in the sun too long, even if you use a sunscreen product. Do not expose babies and young children directly to the sun. Dermatologist tested on all skin types and tones. Clinically proven efficacy / Non comedogenic drbrandtskincare.com DARE TO CARE Cosmetic Dermatology LLC, Miami, FL 33172 In the US call 800-234-1066 BIORIUS / EU: Wavre, BE UK: London WC2H 9JQ, GB Made in U.S.A.
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