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Sabal mineral sunscreen broad sprectrum spf 30 - Medication Information

Product NDC Code 84446-505
Drug Name

Sabal mineral sunscreen broad sprectrum spf 30

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Zinc oxide 140 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name SABAL SUN LLC
Packages
Package NDC Code Description
84446-505-00 89 ml in 1 tube (84446-505-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Zinc Oxide 14% 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 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeve 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), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Chamomilla Recutita (Chamomile) Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Ethyl Vanillin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydrogenated Methyl Abietate, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Spirea Ulmaria (Meadowsweet) Extract, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

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. 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.
SABAL Mineral Sunscreen Broad Sprectrum SPF 30 ZINC OXIDE ALOE VERA LEAF WATER BUTYLOCTYL SALICYLATE SHEA BUTTER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CHAMOMILE CITRIC ACID MONOHYDRATE COCONUT OIL DECYL GLUCOSIDE ETHYL VANILLIN GLYCERIN GLYCERYL LAURATE GLYCERYL MONOSTEARATE HELIANTHUS ANNUUS FLOWERING TOP HYDROGENATED METHYL ABIETATE HYDROXYETHYL CELLULOSE, UNSPECIFIED LAVENDER OIL PUNICA GRANATUM ROOT BARK STEARIC ACID XANTHAN GUM CORN 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 the product in this container from excessive heat and direct sunlight.

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? Email: [email protected] Call:(727)-209-7730

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 doctor if 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 feeding
If pregnant or breastfeeding, 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: 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 doctor if 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 breastfeeding, 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

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