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| Product NDC Code | 69435-1505 | ||||
|---|---|---|---|---|---|
| Drug Name | Sun and shine mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Peer Pharm Ltd. | ||||
| 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 24.5% Purpose Sunscreen
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 40 minutes of swimming or sweating • immediately after towel drying • at least every 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 am to 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aqua, coco-caprylate, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, cetearyl olivate, sorbitan olivate, caprylyl glycol, glycerin, polyhydroxystearic acid, aloe barbadensis leaf juice, panthenol, triethoxycaprylylsilane, cetearyl alcohol, tocopherol, butyrospermum parkii (shea) butter, silica, silica dimethyl silylate, xanthan gum, caprylhydroxamic acid, propanediol, sodium phytate, dipotassium glycyrrhizate, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, citric acid
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.SUN and SHINE MINERAL SUNSCREEN ZINC OXIDE TOCOPHEROL CETEARYL ETHYLHEXANOATE HEXASODIUM PHYTATE CALENDULA OFFICINALIS SEED OIL TRIETHOXYCAPRYLYLSILANE SHEA BUTTER SILICA DIMETHYL SILYLATE XANTHAN GUM CAPRYLHYDROXAMIC ACID DIPOTASSIUM GLUCOSE-6-PHOSPHATE POLYHYDROXYSTEARIC ACID (2300 MW) CAPRYLYL GLYCOL COCO-CAPRYLATE SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) ISOBUTANE WATER 1-(ETHYLTRISULFANYL)PROPANE TRIOCTYLDODECYL CITRATE ACRYLATES CROSSPOLYMER-4 CETEARYL OLIVATE SORBITAN OLIVATE CASTOR OIL GLYCERIN PROPANEDIOL 1-PHOSPHATE CHAMOMILE PANTHENOL ALOE 1,4-BUTANEDITHIOL 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.Product label image description image description
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
Other information protect this product from excessive heat and sun
Questions or Comments Call 951-297-7976 or visit www.kcare.co.il
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, call a poison control center or get medical help right away.
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 or irritation develops and lasts. Keep out of reach of children. If swallowed, call a poison control center or get medical help 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