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Product NDC Code | 72962-102 | ||||
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Drug Name | Ethical zinc daily wear light sunscreen 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 | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | ETHICAL ZINC PTY LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS ZINC OXIDE 22.70%
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 CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS PURIFIED WATER, COCO CAPRYLATE/CAPRATE, MEDIUM CHAIN TRIGLYCERIDES, OCTYLDODECANOL, GLYCEROL, CETEARYL ALCOHOL, POLYGLYCERYL-3 POLYRICINOLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, GLUCONOLACTONE, ISOSTEARIC ACID, SODIUM CHLORIDE, SODIUM BENZOATE, CETEARYL GLUCOSIDE, EDTA, XANTHAN GUM.
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.USE HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF 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.ETHICAL ZINC DAILY WEAR LIGHT SUNSCREEN SPF-50 ZINC OXIDE WATER COCO-CAPRYLATE/CAPRATE MEDIUM-CHAIN TRIGLYCERIDES OCTYLDODECANOL GLYCERIN CETOSTEARYL ALCOHOL POLYGLYCERYL-3 RICINOLEATE PEG-30 DIPOLYHYDROXYSTEARATE GLUCONOLACTONE ISOSTEARIC ACID SODIUM CHLORIDE SODIUM BENZOATE CETEARYL GLUCOSIDE EDETIC ACID XANTHAN GUM 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.01b LBL_Daily Wear Light Sunscreen SPF-50_100g
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.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
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 OCCURS.
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