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Product NDC Code | 54136-371 | ||||
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Drug Name | Sun serum drops |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | M020 | ||||
Labeler Name | Better Planet Brands LLC | ||||
Packages |
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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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients DICAPRYLYL CARBONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYCLATE, TRIDECTYL SALICYCLATE, COCO-CAPRYLATE/ CAPRATE, COCONUT ALKANES, SORBITAN SESQUIOLEATE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CETYL ALCOHOL, STEARYL ALCOHOL, TOCOPHERYL ACETATE (VITAMIN E), CALENDULA OFFICINALIS (POT MARIGOLD) FLOWER, OLEA EUROPEA (OLIVE) FRUIT OIL, LECITHIN, ETHYLHEXYGLYCERIN.
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
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.Sun Serum Drops Zinc Oxide COCONUT ALKANES SORBITAN SESQUIOLEATE STEARYL ALCOHOL TRIDECYL SALICYLATE BUTYROSPERMUM PARKII (SHEA) BUTTER ZINC OXIDE ZINC OXIDE CALENDULA OFFICINALIS FLOWER SOYBEAN LECITHIN OLEA EUROPAEA (OLIVE) FRUIT OIL CETYL ALCOHOL BUTYLOCTYL SALICYLATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE .ALPHA.-TOCOPHEROL ACETATE, D- COCO-CAPRYLATE/CAPRATE DICAPRYLYL CARBONATE ETHYLHEXYLGLYCERIN CAPRYLIC/CAPRIC TRIGLYCERIDE
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.Box
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.
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 product is 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 some
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll-free 877.902.2873
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.
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 • Do not use on damaged or broken skin. • Stop use and ask a doctor if rash occurs. • Keep out of reach of children. If product is 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