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Attitude sunly lip balm unscented spf 15 - Medication Information

Product NDC Code 61649-093
Drug Name

Attitude sunly lip balm unscented spf 15

Type Brand
Active Ingredients
Zinc oxide 10 g/100g
Route TOPICAL
Dosage Form STICK
Application Number M020
Labeler Name 9055-7588 Quebec Inc. DBA Attitude
Packages
Package NDC Code Description
61649-093-01 8.5 g in 1 tube (61649-093-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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.
Adults and children older than 6 months. 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, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecanol, CI 77491 (Iron Oxides), CI 77492 (Iron Oxides), CI 77742 (Manganese Violet), CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Stearoyl Glutamic 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.
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 Sunly Lip balm Unscented SPF 15 Zinc oxide ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES SHEA BUTTER BEHENYL BEHENATE SUNFLOWER OIL TRIHYDROXYSTEARIN STEAROYL GLUTAMIC ACID FERRIC OXIDE RED HELIANTHUS ANNUUS SEED WAX GLYCERYL MONOBEHENATE FERRIC OXIDE YELLOW ARGAN OIL CASTOR OIL CANDELILLA WAX OCTYLDODECANOL MANGANESE VIOLET COCONUT OIL POLYHYDROXYSTEARIC ACID (2300 MW) FERROSOFERRIC OXIDE JOJOBA OIL

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 natural care SPF 15 unscented lip balm universal shade BROAD SPECTRUM SUNSCREEN SPF 15 UVA UVB + NON NANO SUNLY Plastic Free Suncare 8.5 g / 0.3 oz. NPN 80109103 Vegan EWG Verified Ocean Lovers 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