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Product NDC Code | 69435-1509 | ||||
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Drug Name | Sun and shine - mineral sunscreen clear facial stick spf 50 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
Application Number | M020 | ||||
Labeler Name | Peer Pharm Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Zinc Oxide 24.5% 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 80 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 a.m. 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 Caprylic/Capric Triglyceride, Coco-Caprylate, Ozokerite, Butyloctyl Salicylate, Polyhydroxystearic Acid, Tocopherol, Cocos Nucifera (Coonut) Oil, Triethoxycaprylylsilane, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Water (Aqua), Bisabolol, Butyrospermum Parkii (Shea) Butter, Calendula Offcinalis(Calendula) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract
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.
Spl product data elements
Usually a list of ingredients in a drug product.Sun and Shine - Mineral Sunscreen Clear Facial Stick SPF 50 Zinc Oxide MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE CERESIN BUTYLOCTYL SALICYLATE POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL COCONUT OIL TRIETHOXYCAPRYLYLSILANE JOJOBA OIL GLYCERIN ALOE VERA LEAF WATER LEVOMENOL SHEA BUTTER CALENDULA OFFICINALIS FLOWER CHAMOMILE ZINC OXIDE ZINC CATION
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
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.Other information protect this product in this container from excessive heat and direct sun. Do not use if the seal is broken.
Questions or comments Call 951-297-7976 or visit www.kcare.co.il
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 a 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