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| Product NDC Code | 79265-8708 | ||||
|---|---|---|---|---|---|
| Drug Name | Babo botanicals daily sheer mineral sunscreen spf 40 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| 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 Ingredients Titanium Dioxide 5.9% Zinc Oxide 3.3%
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 use a water resistant sunscreen if swimming or sweating reapply: immediately after towel drying at least every 2 hours Sun Protection Measures Sun exposure increases risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Beeswax*, Butyrospermum Parkii (Shea Butter)*, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Coco-Glucoside, Dehydroxanthan Gum, Dicaprylyl Carbonate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogen Dimethicone, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methyl Dihydroabietate, Myristyl Alcohol, Myristyl Glucoside, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Pongamia Pinnata Seed Oil, Ricinus Communis (Castor) Seed Oil, Rosa Canina Fruit Extract, Simmondsia Chinensis (Jojoba) Seed Oil*, Triethoxycaprylylsilane, Water (Aqua). *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.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.Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40 Zinc Oxide, Titanium Dioxide TRIETHOXYCAPRYLYLSILANE ALUMINUM HYDROXIDE JOJOBA OIL CASTOR OIL ROSA CANINA FRUIT PHENYLETHYL ALCOHOL CETOSTEARYL ALCOHOL DEHYDROXANTHAN GUM SUNFLOWER OIL ETHYLHEXYLGLYCERIN METHYL DIHYDROABIETATE HYDROGEN DIMETHICONE (13 CST) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) DICAPRYLYL CARBONATE AVOCADO OIL WATER SHEA BUTTER MYRISTYL GLUCOSIDE KARUM SEED OIL COCO GLUCOSIDE MYRISTYL ALCOHOL ALOE VERA LEAF GLYCERIN ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE GREEN TEA LEAF YELLOW WAX
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 1
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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.
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 rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
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.
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