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| Product NDC Code | 83260-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Daily broad spectrum serum solardrops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Motley Brands LLC | ||||
| 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 Ingredients Non-Nano Zinc Oxide 24.5%
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.Drug Facts
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), C13-15 Alkane, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Propanediol, Kaolin, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Opuntia Ficus-Indica (Prickly Pear Cactus) Leaf Cell Extract, Balanites Aegyptiaca (Desert Date) Kernel Oil, Hippophae Rhamnoides (Sea Buckthorn) Kernel Extract, Dipteryx Odorata, Lavandula Angustifolia (Lavender) Oil, Origanum Majorana (Sweet Marjoram) Leaf Oil, Pogostemon Cablin (Patchouli) Oil, Polycitronellol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polyquaternium-90, Bentonite, Sodium Chloride, Squalane, Triethyl Citrate, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (CI 77491, CI 77492)
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.Daily Broad Spectrum Serum Solardrops Zinc Oxide TRIETHYL CITRATE ETHYLHEXYLGLYCERIN MEDIUM-CHAIN TRIGLYCERIDES POLYHYDROXYSTEARIC ACID (2300 MW) KAOLIN POLYGLYCERYL-3 PENTARICINOLEATE HIPPOPHAE RHAMNOIDES SEED C13-15 ALKANE PROPANEDIOL .BETA.-CITRONELLOL, (R)- BENTONITE ETHYL MACADAMIATE SWEET MARJORAM OIL POGOSTEMON CABLIN LEAF OIL ZINC OXIDE ZINC OXIDE ISOSTEARIC ACID PHENOXYETHANOL SODIUM CHLORIDE FERRIC OXIDE RED WATER LAVENDER OIL SQUALANE OPUNTIA FICUS-INDICA LEAF ALMOND OIL LECITHIN, SUNFLOWER DIPTERYX ODORATA SEED DESERT DATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE
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.25X110 SolardropsSPF-A Tube Onekind Solardrops Carton-v2-outlined (1)
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
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally 15 minutes before sun exposure • reapply • after 80 minutes of swimming or sweating • immediately after towel drying • at least ever 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: Ask doctor
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 ■ may stain fabrics
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? E-mail [email protected] or call 323-275-9380
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 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.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