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Product NDC Code | 74154-012 | ||||
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Drug Name | Kiss my face bare naked 30 mineral sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | part352 | ||||
Labeler Name | Windmill Health Products, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Titanium dioxide 7.8%
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 liberally 15 minute before sun exposure. Hold 4 to 6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face. Do not apply in windy conditions. Use in well-ventilated areas and avoid inhalation. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other sun protection measures including: Limit time in sun, especially from 10am to 2pm. Wear long-sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol , Coco Glucoside, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Fragrance (Parfum) Natural fragrance , Ginkgo Biloba Leaf Extract, Glycerin, Heptyl Undecylenate, Impatiens Balsamina (Garden Balsam) Leaf Extract, Methyl Dihydroabietate, Persea Gratissima (Avocado) Fruit Extract, Silica, Tocopherol, Water (Aqua)
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 Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases 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.Kiss My Face Bare Naked 30 Mineral Sunscreen titanium dioxide Titanium dioxide Titanium dioxide ALOE VERA LEAF ALUMINUM OXIDE Bentonite Butyloctyl Salicylate Caprylhydroxamic Acid Caprylyl Glycol SAFFLOWER OIL CETOSTEARYL ALCOHOL Coco Glucoside CUCUMBER Ethylhexylglycerin GINKGO Glycerin Heptyl Undecylenate IMPATIENS BALSAMINA LEAF Methyl Dihydroabietate AVOCADO SILICON DIOXIDE TOCOPHEROL WATER
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 - 177 ml Can Label KISS MY FACE ® 30 bare naked ® mineral sunscreen lightweight & ultra sheer** broad spectrum SPF30 water resistant (80 minutes) hydrates & protects aloe vera ginkgo biloba REEF FRIENDLY* 6 fl oz (177 ml) PRINCIPAL DISPLAY PANEL - 177 ml Can 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 800-822-4320 Or visit www.kissmyface.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 skin rash or irritation develops and lasts.
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product from excessive heat and direct 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 Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. 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 skin rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.
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