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| Product NDC Code | 61649-983 | ||||
|---|---|---|---|---|---|
| Drug Name | Attitude - leaves bar - lip balm - spf 15 - mango |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | 9055-7588 Qubec Inc. DBA Attitude | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Medicinal ingredient Zinc oxide (10%)
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 and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after eating or drinking. FOR EXTERNAL USE ONLY.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive or non-medicinal ingredients cocos nucifera (coconut) oil, polyhydroxystearic acid, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) seed wax, behenyl behenate, caprylic/capric triglyceride, ricinus communis (castor) seed oil, argania spinosa kernel oil, flavor, euphorbia cerifera (candelilla) wax, coco-caprylate/caprate, rosmarinus officinalis (rosemary) leaf extract, caprylic/capric triglyceride *flavour , vanillin , 3-hexenol , hexyl hexanoate , alpha pinene .
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.Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango ZINC OXIDE COCONUT OIL POLYHYDROXYSTEARIC ACID (2300 MW) SHEA BUTTER SUNFLOWER OIL HELIANTHUS ANNUUS SEED WAX BEHENYL BEHENATE MEDIUM-CHAIN TRIGLYCERIDES CASTOR OIL ARGAN OIL CANDELILLA WAX COCOYL CAPRYLOCAPRATE ROSEMARY VANILLIN 3-HEXEN-1-OL, (3Z)- HEXYL HEXANOATE .ALPHA.-PINENE 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.PRINCIPAL DISPLAY PANEL - 8.5 g Tube Carton PLASTIC FREE ATTITUDE™ natural care 15 SPF leaves bar™ lip balm MANGO • EWG VERIFIED • FOR YOUR HEALTH • EWG.ORG NPN 80109103 8.5 g / 0.3 OZ. PRINCIPAL DISPLAY PANEL - 8.5 g 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. If rash occurs, stop use and ask a doctor.
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.
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 Store at temperatures below 90°F.
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. If rash occurs, stop use and ask a doctor. When using this product keep out of eyes. Rinse with water to remove. 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