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Product NDC Code | 61649-045 | ||||
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Drug Name | Attitude oceanly phyto-sun lip balm spf 30 baby rose |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
Application Number | M020 | ||||
Labeler Name | 9055-7588 Quebec Inc. DBA Attitude | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc oxide (20 %)
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.Adults. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours, after eating or drinking. Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses. Use a water resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Ricinus Communis (Castor) Seed Oil, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Capryloyl Glycerin/Sebacic Acid Copolymer, Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Behenate, C10-18 Triglycerides, C18-38 Alkyl Hydroxystearoyl Stearate, Pentadesma Butyracea Seed Butter, CI 77742 (Manganese Violet), Euphorbia Cerifera (Candelilla) Wax, CI 77491 (Iron Oxides), Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), Octyldodecanol, Tocopherol, Stearoyl Glutamic Acid, Jojoba Esters, Trihydroxystearin, Ascophyllum Nodosum Extract, Crithmum Maritimum Extract, Fucus Vesiculosus (Bladderwrack) Extract, Laminaria Saccharina Extract, Plankton Extract, Ascorbyl Palmitate.
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.Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose Zinc oxide ZINC OXIDE ZINC OXIDE COCONUT OIL MEDIUM-CHAIN TRIGLYCERIDES CASTOR OIL POLYHYDROXYSTEARIC ACID (2300 MW) HELIANTHUS ANNUUS SEED WAX CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) SUNFLOWER OIL PENTADESMA BUTYRACEA WHOLE MANGANESE VIOLET FERRIC OXIDE RED GLYCOGEN STEAROYL GLUTAMIC ACID TRIHYDROXYSTEARIN ASCOPHYLLUM NODOSUM CRITHMUM MARITIMUM FUCUS VESICULOSUS SACCHARINA LATISSIMA ASCORBYL PALMITATE HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) COCOA BUTTER C10-18 TRIGLYCERIDES BEHENYL BEHENATE C18-38 ALKYL HYDROXYSTEAROYL STEARATE CANDELILLA WAX OCTYLDODECANOL .ALPHA.-TOCOPHEROL JOJOBA OIL CORN
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.ATTITUDE TM OCEANLY PLASTIC FREE BEAUTY TM SPF 30 PHYTO-SUN Lip balm Baby rose Broad spectrum sunscreen Zinc oxide Phytoglycogen Seaweed Vegan Collagen-like NPN 80125337 8.5 g / 0.3 oz. EWG Verified Vegan FSC Certified Made in Canada Dermatologically tested 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 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? 1-855-509-7225
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 consult a doctor if rash occurs.
Storage and handling
Information about safe storage and handling of the drug product.Store at temperatures < 90F and protect from direct sun. Avoid contact of 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.For external use only. Do not use on broken skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs.
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