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| Product NDC Code | 54136-946 | ||||
|---|---|---|---|---|---|
| Drug Name | Seriously soothing face cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Better Planet Brands 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 ingredients Zinc Oxide 15.50%
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 minutes before sun exposure * reapply: * after 80 minutes of swimming or sweating. * immediately after towel drying. * at least every 2 hours. * Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: * limit time in the sun, especially from 10 a.m.-2 p.m. * wear long-sleeve shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Eau), Coconut Alkanes, Glycerin, Squalane, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Panthenol, Tocopherol, Niacinamide, Tanacetum Annuum Flower Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Argania Spinosa Kernel Oil, Sodium PCA, Allantoin, Lecithin, Bisabolol, Pullulan, Xanthan Gum, Sclerotium Gum, Caprylyl Glycol, Coco-Caprylate/Caprate, Heptyl Undecylenate, Polyhydrostearic Acid, Cetearyl Glucoside, Silica, Hexylene Glycol, Caprylhydroxamic Acid, Ethylhexylglycerin.
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 * Help prevent sunburn * if used as directed with other sun protection measures (see Directions), decreases the 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.Seriously Soothing Face Cream Zinc Oxide COCO-CAPRYLATE/CAPRATE TANACETUM ANNUUM FLOWERING TOP OIL COCONUT ALKANES PANTHENOL POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL BETASIZOFIRAN ALLANTOIN CETEARYL GLUCOSIDE GLYCERIN NIACINAMIDE PULLULAN SQUALANE ETHYLHEXYLGLYCERIN SORBITAN OLIVATE XANTHAN GUM SODIUM PYRROLIDONE CARBOXYLATE CETEARYL OLIVATE CETOSTEARYL ALCOHOL ALOE VERA LEAF SHEA BUTTER CAPRYLHYDROXAMIC ACID ZINC OXIDE ZINC OXIDE ARGAN OIL LEVOMENOL CAPRYLYL GLYCOL HEPTYL UNDECYLENATE COCONUT OIL HEXYLENE GLYCOL WATER SILICON DIOXIDE SOYBEAN 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.Face cream box Face cream tube
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 product is swallowed get medical help or contact a Poison Control Center right away. May stain some fabrics.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information * Protect this product from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-877-902-2873
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 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 the product * keep out of eyes. Rinse with water to remove.
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. When using the product * keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away. May stain some fabrics.
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