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| Product NDC Code | 79265-8065 | ||||
|---|---|---|---|---|---|
| Drug Name | Babo baby face mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | Babo Botanicals, 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 Active Ingredient: Zinc Oxide Purpose: Sunscreen
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 to exposed areas 15 minutes before sun exposure. Children under 6 months: Ask a doctor. Reapply: after 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 protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. and wear long-sleeve shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Olivate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Jojoba Esters, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Tocopherol (Vitamin E). *Certified 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.Use 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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Babo Baby Face Mineral Sunscreen Mineral Sunscreen TAMANU OIL JOJOBA OIL TOCOPHEROL HYDROGENATED JOJOBA OIL, RANDOMIZED ORYZANOL WHITE WAX CHAMOMILE LEVOMENOL CALENDULA OFFICINALIS FLOWER CANDELILLA WAX SHEA BUTTER RICE BRAN OIL OCTYLDODECYL OLEATE FILIPENDULA ULMARIA FLOWER COCOA BUTTER CALOPHYLLUM TACAMAHACA SEED OIL SUNFLOWER OIL AVOCADO OIL NASTURTIUM OFFICINALE FLOWERING TOP ZINC OXIDE ZINC OXIDE
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 Labeling 8065
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.Principal Display Panel Baby Face Mineral Sunscreen Sheer & Gentle Broad Spectrum SPF 50 70% Organic Ingredients Water Resistant (80 Minutes) Zinc Oxide Mineral Sunscreen Fragrance Free Net Wt 0.6 oz / 17 g
DRUG FACTS PANEL Drug Facts Panel
Distributed by Dist: by Babo Botanicals, Inc. 60 East 56th Street New York, NY 10022
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 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 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 doctor if rash occurs. | Keep out of reach of children. If swallowed get medical help or contact a Poison Control center right away. May stain some fabrics and surfaces.
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