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| Product NDC Code | 79265-7978 | ||||
|---|---|---|---|---|---|
| Drug Name | Babo botanicals super shield mineral sunscreen spf50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, SPRAY | ||||
| 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 4.3% Zinc Oxide 14.7%
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 Shake well Hold container 4 to 6 inches from the skin to apply Apply liberally 15 minutes before sun exposure Do not spray directly into face Spray into hands and then apply to face Do not spray in windy condition Use in well ventilated area 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 protection measures including: 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 Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Glycerin, Bisabolol*, Tocopherol, Bentonite, Caprylyl Glycol, Coco-Glucoside, Citric Acid, Sodium Gluconate, Cellulose Gum, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Caprylhydroxamic Acid, Polyhydroxystearic Acid, Alumina, Silica. *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. 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 Botanicals Super Shield Mineral Sunscreen SPF50 Zinc Oxide, Titanium Dioxide BUTYLOCTYL SALICYLATE WATER CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM CITRIC ACID MONOHYDRATE COCO GLUCOSIDE GLYCERIN HEPTYL UNDECYLENATE NASTURTIUM OFFICINALE FLOWERING TOP SODIUM GLUCONATE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL LEVOMENOL SILICON DIOXIDE SODIUM STEAROYL GLUTAMATE ALOE VERA LEAF METHYL DIHYDROABIETATE POLYHYDROXYSTEARIC ACID (2300 MW) ZINC OXIDE ZINC OXIDE FILIPENDULA ULMARIA FLOWER ALUMINUM OXIDE BENTONITE CALENDULA OFFICINALIS FLOWER CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) CHAMOMILE COCONUT OIL CELLULOSE, MICROCRYSTALLINE OLIVE OIL PROPANEDIOL CETOSTEARYL ALCOHOL SUNFLOWER OIL TOCOPHEROL 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.Product Packaging 1
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.Drug Facts
Questions or comments? Call 1-800-422-2987 Mon - Fri 9:00AM - 5:00PM EST
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 immediately
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. May stain some fabrics and surfaces.
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. Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. 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 immediately
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