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Product NDC Code | 55165-0301 | ||||
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Drug Name | Prebiotix spf 45 glow |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Juice Beauty | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 22%
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 Due to the nature of mineral formulations shake and knead the tube before use. Moisturize daily by applying generously and evenly 15 minutes before sun exposure. May be used over moisturizer or alone. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe barbadensis leaf juice certified organic ingredient , butyloctyl salicylate, caprylic/capric triglyceride plant-derived , polyester-8, glycerin , cetearyl alcohol , glyceryl stearate , glycolipids , squalane , sorbitan sesquioleate , isoamyl laurate , vitis vinifera ( grape ) seed oil , simmondsia chinensis ( jojoba ) seed oil , hyaluronic acid , coco-glucoside , hydrolyzed jojoba esters , tocopherol ( Vitamin E ) , bisabolol , ectoin , hydrolyzed viola tricolor extract , phyllanthus emblica fruit extract , inulin , glyceryl caprylate , mica, iron oxides, caprylhydroxamic acid , polyhydroxystearic acid, lysolecithin , sclerotium gum , xanthan gum , pullulan , sodium stearoyl glutamate, sodium riboflavin phosphate, leuconostoc/ radish root ferment filtrate , maltodextrin , titanium dioxide, silica, citric acid.
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.PREBIOTIX SPF 45 Glow Zinc Oxide Zinc Oxide Zinc Oxide ALOE VERA LEAF BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) GLYCERIN CETOSTEARYL ALCOHOL GLYCERYL STEARATE SE PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS SQUALANE SORBITAN SESQUIOLEATE ISOAMYL LAURATE GRAPE SEED OIL JOJOBA OIL HYALURONIC ACID COCO GLUCOSIDE POTASSIUM HYDROLYZED JOJOBA ESTERS TOCOPHEROL LEVOMENOL ECTOINE VIOLA TRICOLOR WHOLE PHYLLANTHUS EMBLICA FRUIT INULIN GLYCERYL MONOCAPRYLATE MICA FERRIC OXIDE YELLOW CAPRYLHYDROXAMIC ACID POLYHYDROXYSTEARIC ACID (2300 MW) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN BETASIZOFIRAN XANTHAN GUM PULLULAN SODIUM STEAROYL GLUTAMATE RIBOFLAVIN 5'-PHOSPHATE SODIUM ANHYDROUS LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE MALTODEXTRIN TITANIUM DIOXIDE SILICON DIOXIDE CITRIC ACID MONOHYDRATE
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.PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton JUICE BEAUTY PREBIOTIX ® SPF 45 Glow Daily Multi-Tasking Moisturizer broad spectrum SPF 45 sunscreen 50 mL / 1.7 fl oz NPN 80122647 PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Email [email protected] or visit www.juicebeauty.com
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect the product in this container 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 a doctor if rash occurs Keep out of reach of children. If product is 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