Mineral Sunscreen
FDA Label NDC 49358-553

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 Sunscreen (NDC 49358-553). 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

Distributed by:
MDSolarSciences Corp.
40 Richards Avenue, 3rd Fl., Norwalk, CT 06854

Otc - Purpose

Active IngredientsPurpose
Titanium Dioxide 8.1%Sunscreen
Zinc Oxide 6.6%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 10a.m. – 2p.m.
      • -Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report serious adverse reactions to Report Reaction, LLC. PO BOX 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Polyethylene, Dimethicone, Butyrospermum Parkii (Shea) Butter, Petrolatum, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Undecylcrylene Dimethicone, Neopentyl Glycol Diheptanoate, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Glyceryl Isostearate, Beeswax, Polyhydroxystearic Acid, Cetyl PEG/PPG- 10/1 Dimethicone, BHT, Benzylidene Dimethoxydimethylindanone, Tetrahexyldecyl Ascorbate

Principal Display Panel - 17 G Tube Carton

MDSolarSciences™

40
MINERAL
SUNSCREEN STICK

BROAD SPECTRUM
SPF 40
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

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

sun care

Net Wt. 17 g - 0.6 Oz.

Principal Display Panel (17 g Tube Carton)

Principal Display Panel (17 g Tube Carton)

* Please review the disclaimer below.