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Product NDC Code | 69555-035 | ||||||||||||
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Drug Name | Ecostick sunscreen spf 35 |
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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 | part352 | ||||||||||||
Labeler Name | Stream2Sea, LLC | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide (Non-Nano) 7% Zinc Oxide (Non-Nano) 6%
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 on cleansed skin prior to 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. - 2 p.m. Wear long-sleeved 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 Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum(Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa(Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic CapricTriglycerides, Helianthus Annuus (Sunflower) Seed Oil*,TheobromaCacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax,Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, GlycerylCaprylate, Silica, Mica, Mixed Tocopherols (Vitamin E). WILD BLUE Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa(Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax,Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Glyceryl Caprylate, Silica, Mica, Spirulina Platensis Extract (and) Trehalose, Mixed Tocopherols (Vitamin E). WILD PINK Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa (Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax, Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Rice Starch, Glyceryl Caprylate, Silica, Mica, Raphanus Sativus (Radish) Root Extract (and) Citric Acid (and) Maltodextrin, Mixed Tocopherols (Vitamin E). TINTED Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa (Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax, Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Glyceryl Caprylate, Silica, Mica, Mixed Tocopherols (Vitamin E), Iron Oxides (C.I.77492, C.I. 77491, C.I. 77499) and Jojoba Esters SUNSCREEN 4 KIDS Extracts of Chamomilla Recutita (Chamomile) Flower* (and) Calendula Officinalis* (and) Camellia Sinensis (Green Tea) Leaf* (and) Ocimum Tenuiflorum (Tulsi) in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax, Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Glyceryl Caprylate, Silica, Mica, Mixed Tocopherols (Vitamin E).
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 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.EcoStick Sunscreen SPF 35 Zinc Oxide, Titanium Dioxide GREEN TEA LEAF HOLY BASIL LEAF ALARIA ESCULENTA OLEA EUROPAEA LEAF COCONUT OIL MEDIUM-CHAIN TRIGLYCERIDES SUNFLOWER OIL COCOA BUTTER CARNAUBA WAX CANDELILLA WAX SORBITAN OLIVATE BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES CETYL ESTERS WAX POLYHYDROXYSTEARIC ACID (2300 MW) STARCH, RICE GLYCERYL MONOCAPRYLATE SILICON DIOXIDE MICA .ALPHA.-TOCOPHEROL ARTHROSPIRA PLATENSIS TREHALOSE RADISH CITRIC ACID MONOHYDRATE MALTODEXTRIN FERRIC OXIDE RED HYDROLYZED JOJOBA ESTERS (ACID FORM) CHAMOMILE CALENDULA OFFICINALIS FLOWER ZINC OXIDE ZINC CATION TITANIUM DIOXIDE TITANIUM DIOXIDE WILD BLUE WILD PINK
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.PRINCIPAL DISPLAY PANEL EcoStick Sport Sunscreen Carton Label EcoStick Sport Sunscreen Container Label EcoStick Sport Screenscreen Wild Blue Carton Label EcoStick Sport Screenscreen Wild Blue Container Label EcoStick Sport Screenscreen Tint Carton Label EcoStick Sport Screenscreen Tint Container Label EcoStick Sport Screenscreen Wild Pink Carton Label EcoStick Sport Screenscreen Wild Pink Container Label EcoStick Sport Screenscreen 4 Kids Carton Label EcoStick Sport Screenscreen 4 Kids Container Label EcoStick Sport Screenscreen Wild Blue Carton Label EcoStick Sport Screenscreen Wild Blue Container Label EcoStick Sport Screenscreen Wild Blue Carton Label EcoStick Sport Screenscreen Wild Blue Container Label EcoStick Sport Screenscreen Tint Carton Label EcoStick Sport Screenscreen Tint Container Label EcoStick Sport Screenscreen Wild Pink Carton Label EcoStick Sport Screenscreen Wild Pink Container Label EcoStick Sport Screenscreen 4 Kids Carton Label EcoStick Sport Screenscreen 4 Kids Container Label
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call 1.863.473.4223 or visit www.stream2sea.com
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product 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