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| Product NDC Code | 55165-0201 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf 8 lip moisturizers |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | part352 | ||||
| Labeler Name | Juice Beauty | ||||
| 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 Ingredient Zinc oxide 4%
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 generously before sun exposure and as needed. Children under 6 months of age, ask a doctor. Generously glide over lips and use often.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Organic plant oils of helianthus annuus (organic sunflower seed oil) certified organic ingredient , ricinus communis (organic castor seed oil) , euphorbia cerifera (candelilla wax), theobroma cacao (organic cocoa seed butter) , cocos nucifera (organic coconut oil) , fragaria ananassa (organic strawberry flavor) , aloe barbadensis (organic aloe oil) , vaccinium corymbosum (organic blueberry flavor) , tocopherol (Vitamin E). May contain titanium dioxide, mica, iron oxides.
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.SPF 8 Lip Moisturizers Zinc Oxide SPF 8 Lip Moisturizer Joyful Zinc Oxide Zinc Oxide Zinc Oxide Sunflower Oil Candelilla Wax COCOA BUTTER Coconut Oil Castor Oil FERRIC OXIDE RED ALOE VERA LEAF TOCOPHEROL Mica Titanium Dioxide SPF 8 Lip Moisturizer Naturally Clear Zinc Oxide Zinc Oxide Zinc Oxide Sunflower Oil Candelilla Wax COCOA BUTTER Coconut Oil Castor Oil ALOE VERA LEAF TOCOPHEROL SPF 8 Lip Moisturizer Playful Zinc Oxide Zinc Oxide Zinc Oxide Sunflower Oil Candelilla Wax COCOA BUTTER Coconut Oil Castor Oil FERRIC OXIDE RED ALOE VERA LEAF TOCOPHEROL Mica 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.PRINCIPAL DISPLAY PANEL - Kit Carton juice BEAUTY THE ORGANIC SOLUTION™ SPF 8 Lip Moisturizers .15 oz / 4.25 g ea PRINCIPAL DISPLAY PANEL - Kit 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? 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 Minimal sun protection product. Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the 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 Skin Cancer/ Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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