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| Product NDC Code | 10596-806 | ||||||||
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| Drug Name | Hello sunday the one for your lips clear lip balm spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | STICK | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Kao USA Inc. | ||||||||
| 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 AVOBENZONE 3% HOMOSALATE 7.3% OCTISALATE 5% OCTOCRYLENE 9%
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 lips before sun exposure. Reapply frequently Do not swallow Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients POLYISOBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA DIMETHYL SILYLATE, BUTYLOCTYL SALICYLATE, SQUALANE, DICAPRYLYL CARBONATE, OCTYLDODECANOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL BEHENATE, FRAGRANCE, SODIUM HYALURONATE, TOCOPHEROL, ORYZA SATIVA (RICE) EXTRACT, ORYZA SATIVA (RICE) GERM EXTRACT, SYNTHETIC WAX, STEARALKONIUM BENTONITE, PHYSALIS ANGULATA EXTRACT, 1,2-HEXANEDIOL, BISABOLOL, CAPRYLYL GLYCOL, ETHYLHEXYL PALMITATE, GLYCINE SOJA (SOYBEAN) OIL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN, BENZYL BENZOATE.
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 ageing 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.Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene OCTISALATE OCTISALATE POLYISOBUTYLENE (1300 MW) HYALURONATE SODIUM RICE GERM SILICON DIOXIDE TRIHYDROXYSTEARIN SILICA DIMETHYL SILYLATE SQUALANE DICAPRYLYL CARBONATE BUTYLOCTYL SALICYLATE OCTYLDODECANOL SHEA BUTTER TOCOPHEROL GLYCERYL MONOBEHENATE SYNTHETIC WAX (1200 MW) 1,2-HEXANEDIOL AVOBENZONE AVOBENZONE PROPYLENE CARBONATE ETHYLHEXYL PALMITATE LEVOMENOL KONJAC MANNAN PHYSALIS ANGULATA WHOLE CAPRYLYL GLYCOL OCTOCRYLENE OCTOCRYLENE BENZYL BENZOATE POLYGLYCERYL-3 DIISOSTEARATE MEDIUM-CHAIN TRIGLYCERIDES SOYBEAN OIL HOMOSALATE HOMOSALATE
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.Product Packaging 1
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
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 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 the product in this container 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? 1-888-426-0695 Monday-Friday, 9 a.m. - 5 p.m. EST
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 only Do not use on damaged or broken skin 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