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| Product NDC Code | 73418-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Baby mineral sunscreen spf55 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Hello Bello | ||||
| 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 Zinc Oxide 20.0%
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.Drug Facts
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis Leaf Extract*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco Glucoside, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Persea Gratissima (Avocado) Fruit Extract*, Polyhydroxystearic Acid, Prunus Armeniaca (Apricot) Kernel Oil*, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water (Aqua) *Organic
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.Baby Mineral Sunscreen SPF55 Zinc Oxide LEVOMENOL BUTYLOCTYL SALICYLATE CAPRYLHYDROXAMIC ACID CETOSTEARYL ALCOHOL CETYL ALCOHOL CHAMOMILE ORANGE OIL DIHEPTYL SUCCINATE POLYHYDROXYSTEARIC ACID STEARATE APRICOT KERNEL OIL SODIUM GLUCONATE HYALURONATE SODIUM SODIUM STEAROYL GLUTAMATE TOCOPHEROL VANILLA BEAN WATER MICROCRYSTALLINE CELLULOSE ARACHIDYL ALCOHOL DOCOSANOL COCOA BUTTER ARACHIDYL GLUCOSIDE CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) CAPRYLYL GLYCOL CARBOXYMETHYLCELLULOSE SODIUM CITRIC ACID MONOHYDRATE COCO GLUCOSIDE COCONUT OIL CUCUMBER GLYCERIN METHYL DIHYDROABIETATE AVOCADO TRIETHYL CITRATE ZINC OXIDE ZINC OXIDE SHEA BUTTER
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.HelloBello_sunscreen_dieline_109C_March2022_AO
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 broken or damaged skin
Instructions for use
Information about safe handling and use of the drug product.Directions Shake well before use Apply liberally and spread evenly by hand 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating, immediately after towel use, at least every 2 hours For children under 6 months of age, ask a doctor Sun Protection Measures Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limiting time in the sun, especially from 10a.m. - 2p.m. Wearing long-sleeved shirts, pants, hats and sunglasses
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 Avoid long-term exposure storage above 40°C (104°F) May stain some fabrics
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 a 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 broken or damaged skin When using this product Keep out of eyes. Rinse with water to remove Stop use and ask a 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