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Product NDC Code | 69555-037 | ||||
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Drug Name | Planet protecting sunscreen 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Stream2Sea, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.DRUG FACTS ACTIVE INGREDIENTS 8.8% Titanium dioxide (Non-Nano)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Deionized Water, Aqueous Extracts of Camellia sinensis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)* and Olea Europa (Olive) Leaf*, Caprylic/Capric Triglyceride, Aloe Barbedensis (Aloe) Leaf juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhydroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Cocos Nucifera (Coconut) Oil*, Stearic acid, Acrylates Copolymer, Magnesium Aluminium Silicate, Sorbitan Palmitate, Tocopherol, Xanthum Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Iron Oxides *ORGANIC INGREDIENTS
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
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.Planet Protecting Sunscreen 30 TITANIUM DIOXIDE WATER GREEN TEA LEAF HOLY BASIL LEAF ALARIA ESCULENTA OLEA EUROPAEA LEAF MEDIUM-CHAIN TRIGLYCERIDES ALOE COCO-GLYCERIDES GLYCERIN CETOSTEARYL ALCOHOL CETYL PALMITATE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN OLIVATE CETEARYL OLIVATE METHYLCELLULOSE, UNSPECIFIED COCONUT OIL STEARIC ACID METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER MAGNESIUM ALUMINUM SILICATE SORBITAN MONOPALMITATE TOCOPHEROL XANTHAN GUM BENZYL ALCOHOL SALICYLIC ACID SORBIC ACID FERROUS OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PLANET PROTECTING SUNSCREEN 30+ NDC 69555-037-30 - 3 FL OZ/90 ML - Label PLANET PROTECTING SUNSCREEN 30+ NDC 69555-037-30 - 3 FL OZ/90 ML - Label
Instructions for use
Information about safe handling and use of the drug product.DIRECTIONS Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours. For children under 6 months of age; ask a doctor. Wear UPF clothing and apply to exposed skin in small amounts to start.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Protect this product from excessive heat and sunlight REEF-LEGAL SUNSCREEN TO PROTECT PALAU AND THE FUTURE OF THE PLANET Many sunscreens contain chemicals that damage the planet's reefs and wildlife when you wear it in the water. This one doesn't. So you can save your skin and the Earth's.
Storage and handling
Information about safe storage and handling of the drug product.OUR PACKAGE IS MADE USING SUGARCANE RESIN, PLEASE RECYCLE Manufactured in the USA by: Stream2Sea | Bowling Green, FL 33834 Questions: 866-960-9513 | Stream2Sea.com
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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes, Rinse with water to remove. Keep babies and young children out of direct sunlight.
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