Miami Beach Bum Spf-50 Blocked Sunscreen Liquid
FDA Label NDC 82812-448

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Miami Beach Bum for the product Miami Beach Bum Spf-50 Blocked Sunscreen (NDC 82812-448). 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 a 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 15%

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 A Doctor

if rash occurs

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Centre right away.

Directions

  • Apply liberally 15 minutes before sun exposure 
  • Reapply:
  • after 80 minutes of swimming or sweating 
  • immidiately after towel drying
  • at least every 2 hours
  • S un 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 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 sunglasess
  • Children under 6 months: Ask a doctor

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Adansonia Digitata (Baobab) Oil, Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Brassica Oleracea (Broccoli) Extract, Butyloctyl Salicylate, C13-16 Isoalkane, Camellia Sinensis (Green tea) Etract, Caprylic/Capric Triglyceride, Carthamus  Tinctorious (safflower) oil, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Triheptanoin, Xanthan Gum, Zemea (Corn) Propanediol.

Questions?

305-399-7580

Package Labeling:

Label1 (Label1)

Label1 (Label1)

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