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| Product NDC Code | 74154-317 | ||||
|---|---|---|---|---|---|
| Drug Name | Kiss my face spf-50 baby mineral sunscreen |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | WINDMILL HEALTH PRODUCTS LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide - 12.00% Purpose Sunscreen
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. 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. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other sun protection measures including: Sun Protection Measures: 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 (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extarct, Citric Acid, Daucus Carota Sative (Carrot) Extract, Decyl Glucoside, Dehydroacetic Acid, Fucus Vesiculosus (Algae) Extract, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Oil, Tagetes Erecta(Lutin) Extract, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum
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 ), decreases risk of skin cancer and early skin aging caused by the sun. Directions
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 SPF-50 Baby Mineral Sunscreen ZINC OXIDE ALOE VERA LEAF WATER ASCORBIC ACID BENZYL ALCOHOL SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL COCONUT OIL CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CITRIC ACID MONOHYDRATE CARROT DECYL GLUCOSIDE DEHYDROACETIC ACID FUCUS VESICULOSUS GLYCERIN GLYCERYL MONOSTEARATE HELIANTHUS ANNUUS FLOWERING TOP HYDROXYETHYL CELLULOSE, UNSPECIFIED AVOCADO OIL JOJOBA OIL .ALPHA.-TOCOPHEROL ACETATE TRIDECYL SALICYLATE XANTHAN GUM ZINC OXIDE ZINC CATION
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.Package Labeling: 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
Other Information Protect this product from excessive heat and direct sun.
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 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.
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: not intended for ingestion. 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 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