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| Product NDC Code | 61649-068 | ||||
|---|---|---|---|---|---|
| Drug Name | Attitude oceanly phyto-sun tinted - spf 15 - broad spectrum sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | Attitude DBA 9055-7588 Qubec Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active 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 Adults and children older than 6 months. Apply generously 15 minutes prior to sun exposure. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing .
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Helianthus Annuus (sunflower) seed wax, jojoba esters, caprylic/capric triglycerides, isopropyl palmitate, olus oil, isostearyl isostearate, zea mays (corn) starch, ricinus communis (castor) seed oil, polyhydroxystearic acid, glycerin, octyldodecanol, behenyl behenate, butyrospermum parkii (shea) butter, capryloyl glycerin / sebacic acid copolymer, aqua / water / eau, octyldodecyl myristate, sucrose laurate, sucrose stearate, acacia decurrens flower wax, polyglycerin-3, euphorbia cerifera (candelilla) wax, glycogen, rosmarinus officinalis (rosemary) leaf extract, fucus vesiculosus (bladderwrack) extract, iron oxides, isopropyl titanium triisostearate.
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.Use 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.Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen ZINC OXIDE HELIANTHUS ANNUUS SEED WAX JOJOBA OIL, RANDOMIZED MEDIUM-CHAIN TRIGLYCERIDES ISOPROPYL PALMITATE CORN OIL C10-18 TRIGLYCERIDES ISOSTEARYL ISOSTEARATE STARCH, CORN CASTOR OIL POLYHYDROXYSTEARIC ACID (2300 MW) GLYCERIN OCTYLDODECANOL BEHENYL BEHENATE SHEA BUTTER CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) WATER OCTYLDODECYL MYRISTATE SUCROSE LAURATE SUCROSE STEARATE ACACIA DECURRENS FLOWER WAX POLYGLYCERIN-3 CANDELILLA WAX GLYCOGEN ROSEMARY FUCUS VESICULOSUS FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW ISOPROPYL TITANIUM TRIISOSTEARATE 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 - 30 g Tube Label ATTITUDE™ OCEANLY PLASTIC FREE BEAUTY™ PHYTO-SUN tinted cream SPF 15 BROAD SPECTRUM SUNSCREEN NPN 80112334 ZINC OXIDE BLADDERWRACK EXTRACT PHYTOGLYCOGEN STICK 30 g | 1 oz. PRINCIPAL DISPLAY PANEL - 30 g Tube Label
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 swallowed, get medical help or contact a Poison Control Center right away.
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 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. Avoid contact of the packaging with water.
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. Stop use and ask doctor if rash occurs. 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