Sabal Mineral Sunscreen Broad Sprectrum Spf 30 Lotion
FDA Label NDC 84446-505

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sabal Sun Llc for the product Sabal Mineral Sunscreen Broad Sprectrum Spf 30 (NDC 84446-505). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses:, warnings:, do not use, when using this product, stop use and ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 14%

Purpose

Sunscreen

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.

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.

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.

Other Information:

Protect the product in this container from excessive heat and direct sunlight.

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.

Package Labeling:

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