Md Mineral Bb Creme Broad Spectrum Spf 50 Water Resistant 80 Min Cream
FDA Label NDC 14268-126

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Englewood Lab, Inc. for the product Md Mineral Bb Creme Broad Spectrum Spf 50 Water Resistant 80 Min (NDC 14268-126). 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 ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Titanium Dioxide 2%.

Zinc Oxide 17%

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

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.

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 and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10a.m. - 2p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

Shake well. Rub in well. •Protect the product in this container from excessive heat and direct sunlight • May stain some fabrics • You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Niacinamide, Caffeine, Ubiquinone (CoQ10), Tetrahexyldecyl Ascorbate (Vitamin C), Squalane, Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Camellia Sinensis Leaf Extract (Green Tea), Silica, Polyhydroxystearic Acid, Triethoxycaprylylsilane, May Contain: (CI 77891, CI 77491, CI 77492, CI 77499)

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