Mineral Beauty Balm
FDA Label NDC 49358-550

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mdsolarsciences for the product Mineral Beauty Balm (NDC 49358-550). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Titanium Dioxide 2%Sunscreen
Zinc Oxide 17% 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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove

Otc - Keep Out Of Reach Of Children

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 10 a.m. – 2 p.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 reaction to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Butyloctyl Salicylate, Polysilicone-15, Tetrahexyldecyl Ascorbate, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxide, Caffeine, Niacinamide, Ubiquinone, Tocopheryl Acetate, Squalane, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract.

Principal Display Panel - 35 G Tube Carton - Light/Medium

MDSolarSciences™

50

MD CRÈME
MINERAL
BEAUTY BALM

light • medium

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

Water resistant (80 minutes)
Non-comedogenic – won't clog pores

sun repair

Net Wt. 35 g - 1.23 Oz.

Principal Display Panel (35 g Tube Carton)

Principal Display Panel (35 g Tube Carton)

Principal Display Panel - 35 G Tube Carton - Medium/Dark

MDSolarSciences™

50

MD CRÈME
MINERAL
BEAUTY BALM

medium • dark

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

Water resistant (80 minutes)
Non-comedogenic – won't clog pores

sun repair

Net Wt. 35 g - 1.23 Oz.

Principal Display Panel (35 g Tube Carton)

Principal Display Panel (35 g Tube Carton)

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