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| Product NDC Code | 62742-4114 | ||||
|---|---|---|---|---|---|
| Drug Name | Kids broad spectrum spf 35 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Allure Labs 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: Zinc Oxide 18.9%
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 liberally 15 minutes before sun exposure. Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Phenoxyethanol, Xanthan Gum, Carageenan, Helionori, Punica Granatum (Pomegranate) Extract, Plantago Lanceolate (Plantain) Leaf Extract, Ascorbyl Palmitate (Vitamin-C), Ethylhexylglycerin.
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: Provide high protection against sunburn. Provide broad spectrum (UVA and UVB) protection. If used as directed with other sun protection measures, 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.Kids Broad Spectrum SPF 35 Zinc Oxide PLANTAGO LANCEOLATA LEAF ASCORBYL PALMITATE SORBITAN MONOSTEARATE CETEARYL GLUCOSIDE ETHYLHEXYLGLYCERIN ZINC OXIDE ZINC OXIDE GLYCERIN PORPHYRA UMBILICALIS CARRAGEENAN WATER STEARYL ALCOHOL POLYHYDROXYSTEARIC ACID STEARATE ISOSTEARIC ACID PUNICA GRANATUM ROOT BARK MEDIUM-CHAIN TRIGLYCERIDES POLYSORBATE 60 STEARIC ACID CETYL ALCOHOL POLYGLYCERYL-3 RICINOLEATE LECITHIN, SOYBEAN XANTHAN GUM
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.Sun Research LLC Santa Cruz, CA www.burnoutsun.com IMGKBSSPF35
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.High sun protection product.
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 1-800-798-7970
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 and ask a doctor if rash or irritation 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.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.
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