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| Product NDC Code | 82465-101 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Essential daily sunscreen |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | part352 | ||||||
| Labeler Name | ANTEDOTUM 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 INGREDIENT ZINC OXIDE 10%
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. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE RISK, REGULARLY USE 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 WATER, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, CETEARYL ALCOHOL, CETEARYL OLIVATE, POLYGLYCERYL-3 DIISOSTEARATE, SORBITAN OLIVATE, TOCOPHEROL, POPULUS TREMULOIDES (ASPEN) BARK EXTRACT, TETRAHEXYLDECYL ASCORBATE, CITRUS AURANTIUM AMARA (BITTER ORANGE)FLOWER OIL, HYDROLYZED PEA PROTEIN, GLYCERIN, GLUCOSE, CETEARYL GLUCOSIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM CHLORIDE, SODIUM SUCCINATE, XANTHAN GUM, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, IRON OXIDES.
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
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.ESSENTIAL DAILY SUNSCREEN Zinc Oxide SODIUM CHLORIDE POLYGLYCERYL-3 DIISOSTEARATE CETEARYL GLUCOSIDE MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL POPULUS TREMULOIDES BARK FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE WATER CETEARYL OLIVATE CITRUS AURANTIUM FLOWER OIL BUTYLENE GLYCOL FERRIC OXIDE RED XANTHAN GUM SODIUM SUCCINATE HEXAHYDRATE DIMETHICONE SORBITAN OLIVATE TOCOPHEROL ZINC OXIDE ZINC OXIDE TETRAHEXYLDECYL ASCORBATE GLYCERIN TRIETHOXYCAPRYLYLSILANE PHENOXYETHANOL PEA PROTEIN ANHYDROUS DEXTROSE ETHYLHEXYLGLYCERIN
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.ESSENTIAL DAILY SUNSCREEN
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.
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