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| Product NDC Code | 61197-209 | ||||
|---|---|---|---|---|---|
| Drug Name | Sun plus skincare spf 50 mineral bronzing body butter coconut |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Pacifica Beauty, 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 Purpose Zinc Oxide 22.0% 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 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. 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 & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caffeine, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Iron Oxides, Lactococcus Ferment Lysate, Methyl Dihydroabietate, Mica, Microcrystalline Cellulose, Octyldodecyl Oleate, Parfum (Natural), Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Titanium Dioxide, Tocopherol, Water.
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.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.Uses Helps 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.
Spl product data elements
Usually a list of ingredients in a drug product.Sun Plus Skincare SPF 50 Mineral Bronzing Body Butter Coconut Zinc Oxide TOCOPHEROL CAPRYLYL GLYCOL OCTYLDODECYL OLEATE TITANIUM DIOXIDE .ALPHA.-BISABOLOL, (+)- FERRIC OXIDE RED METHYL DIHYDROABIETATE WATER CARBOXYMETHYLCELLULOSE SODIUM CETOSTEARYL ALCOHOL MICA CELLULOSE, MICROCRYSTALLINE POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM GLUCONATE ZINC OXIDE ZINC OXIDE SHEA BUTTER DOCOSANOL CAFFEINE CAPRYLHYDROXAMIC ACID CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) CETYL ALCOHOL COCO GLUCOSIDE COCONUT OIL HYALURONATE SODIUM SODIUM STEAROYL GLUTAMATE COCOA BUTTER GLYCERIN CITRIC ACID MONOHYDRATE DIHEPTYL SUCCINATE ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE BUTYLOCTYL SALICYLATE
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.Sun Plus Skincare SPF 50 Mineral Bronzing Body Butter Coconut Label Sun Plus Skincare SPF 50 Mineral Bronzing Body Butter Coconut Label
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.
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 toll free 1-888-322-2466 Pacifca Beauty LLC Portland, Oregon.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat and direct sun. Can stain clothing. Keep away from clothes.
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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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