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| Product NDC Code | 73291-0003 | ||||||||||
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| Drug Name | Sunbetter broad spectrum spf 75 sunscreen tone smart |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | SKINBETTER SCIENCE LLC | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 3.5% Zinc Oxide 10.0%
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 liberally and evenly 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. immediately after towel drying. 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 1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Allantoin, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Butyloctyl Salicylate, Camellia Oleifera Leaf Extract, Capparis Spinosa Fruit Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetyl Dimethicone, Dimethicone, Disteardimonium Hectorite, Glycerin, Himanthalia Elongata Extract, Iron Oxides (CI 77491, CI 77492, CI 77499), Mica, Niacinamide, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Opuntia Ficus-Indica Stem Extract, Panthenol, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyglyceryl-3 Sorbityl Linseedate, Polyglyceryl-4 Oleate, Polygonum Aviculare Extract, Polyhydroxystearic Acid, Polymethyl Methacrylate, Potassium Sorbate, Silica, Sodium Benzoate, Sodium Chloride, Squalane, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethyl Citrate, Tropolone, Ubiquinone, Water, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.
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.sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart Zinc Oxide, Titanium Dioxide SODIUM BENZOATE SODIUM CHLORIDE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER ALLANTOIN ALUMINUM OXIDE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL STARCH, CORN TRIETHYL CITRATE UBIDECARENONE WATER SILICON DIOXIDE DODECAMETHYLPENTASILOXANE OPUNTIA FICUS-INDICA STEM PHENYLETHYL ALCOHOL PHENOXYETHANOL POLY(METHYL METHACRYLATE; 450000 MW) SQUALANE STEARIC ACID CAPER BERRY CETYL DIMETHICONE 45 TITANIUM DIOXIDE TITANIUM DIOXIDE .ALPHA.-BISABOLOL, (+/-)- BUTYLOCTYL SALICYLATE CAMELLIA OLEIFERA LEAF CERIC OXIDE DISTEARDIMONIUM HECTORITE HIMANTHALIA ELONGATA MICA NIACINAMIDE DIMETHICONE GLYCERIN FERRIC OXIDE RED BLACK OLIVE OLEA EUROPAEA LEAF PANTHENOL PHENYL TRIMETHICONE POLYGLYCERYL-4 OLEATE POLYGONUM AVICULARE TOP POLYHYDROXYSTEARIC ACID (2300 MW) POTASSIUM SORBATE 1,2-HEXANEDIOL TROPOLONE 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.Principal Display Panel sunbetter™ Advanced Mineral Protection BROAD SPECTRUM SPF 75 SUNSCREEN LOTION TONE SMART Water-Resistant (80 Minutes) Mineral Actives skinbetter science® 1.7 FL.OZ. (50 ML) PDP
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 Drug Facts
Instructions for use
Information about safe handling and use of the drug product.Directions 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. Apply liberally and evenly 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. use a water resistant sunscreen if swimming or sweating.
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.
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? 800-538-5600
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