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| Product NDC Code | 79753-009 | ||||
|---|---|---|---|---|---|
| Drug Name | Baby bare republic mineral sunscreen softstick 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 | COOLA LLC | ||||
| 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.Drug Facts Active Ingredients Zinc Oxide 17.9% Purpose Suncreen
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 spection SPF of 15 or higher and other sun protection measures including: SPF of 15 or higher and other sun protection ● limit time in the sun, especially from: 10 a.m. - 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 Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethyl Ferulate, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Isododecane, Neopentyl Glycol Diheptanoate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Stearyl Alcohol, Tocopherol, Triethoxycaprylylsilane
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
Purpose
Information about the drug product’s indications for use.Purpose Suncreen
Spl product data elements
Usually a list of ingredients in a drug product.Baby Bare Republic Mineral Sunscreen SoftStick SPF 50 ZINC OXIDE ZINC OXIDE ZINC CATION SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS CHAMOMILE DIMETHICONE ETHYL FERULATE COTTONSEED OIL HELIANTHUS ANNUUS SEED WAX HYDROGENATED RAPESEED OIL ISODODECANE NEOPENTYL GLYCOL DIHEPTANOATE POLYHYDROXYSTEARIC ACID (2300 MW) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) STEARYL ALCOHOL TOCOPHEROL TRIETHOXYCAPRYLYLSILANE
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.COOLA Label BABY BARE REPUBLIC MINERAL SUNSCREEN Softstick 0.9 OZ / 25 g *Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. All Rights Reserved. WWW.GOBAREOUTSIDE.COM res BabyBare
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.Questions or comments? Call 760-940-2125
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.
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 direct sun
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if skin rash occurs
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 doctor if skin 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