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| Product NDC Code | 79265-8579 | ||||
|---|---|---|---|---|---|
| Drug Name | Babo baby skin mineral sunscreen ff |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | part352 | ||||
| Labeler Name | Babo Botanicals, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 14.5%; 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. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying. 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. Children under 6 months; ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients BENTONITE BISABOLOL* BUTYLOCTYL SALICYLATE CALENDULA OFFICINALIS FLOWER EXTRACT* CAPRYLHYDROXAMIC ACID CAPRYLIC/CAPRIC TRIGLYCERIDE CAPRYLYL GLYCOL CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL CELLULOSE GUM CETEARYL ALCOHOL CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT* COCO GLUCOSIDE GLYCERIN* HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL* JOJOBA ESTERS METHYL DIHYDROABIETATE MICROCRYSTALLINE CELLULOSE NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT* POLYHYDROXYSTEARIC ACID PROPANEDIOL PUERARIA LOBATA (KUDZU) ROOT EXTRACT* SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT* TETRADECANE TOCOPHEROL WATER (AQUA)
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 Baby Skin Mineral Sunscreen FF Mineral Sunscreen PUERARIA MONTANA VAR. LOBATA ROOT TETRADECANE WATER BENTONITE CAPRYLYL GLYCOL LEVOMENOL CETOSTEARYL ALCOHOL CHAMOMILE GLYCERIN SUNFLOWER OIL HYDROGENATED JOJOBA OIL, RANDOMIZED METHYL DIHYDROABIETATE PROPANEDIOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM BUTYLOCTYL SALICYLATE CALENDULA OFFICINALIS FLOWER CAPRYLHYDROXAMIC ACID MEDIUM-CHAIN TRIGLYCERIDES SAFFLOWER OIL COCO GLUCOSIDE MICROCRYSTALLINE CELLULOSE NASTURTIUM OFFICINALE FLOWERING TOP POLYHYDROXYSTEARIC ACID (2300 MW) FILIPENDULA ULMARIA FLOWER TOCOPHEROL 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.79265-8579-6 6 fl. oz. / 177 mL 8579 Front and Drug Facts Panel
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.SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide
Questions and comments Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 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 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. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.
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 eye. 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.
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