Dr. Brandt Sun Shield Spf 50 Liquid
FDA Label NDC 81568-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Brandt for the product Dr. Brandt Sun Shield Spf 50 (NDC 81568-101). 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, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

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.

When using this product

  • Keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.

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 generously and evenly 15 minutes before sun exposure
  • Children under 6 months of age: Ask a doctor
  • Sun 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 value 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.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.

Other Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Isododecane, Polyglyceryl-6 Polyricinoleate, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Trimethylsiloxysilicate, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Isoamyl Laurate, Neopentyl Glycol Diheptanoate, Polyglyceryl-10 Dioleate, Lecithin, Polyhydroxystearic Acid, Ectoin, Polymethylsilsesquioxane, Polysilicone-11, Disteardimonium Hectorite, Butyrospermum Parkii (Shea) Butter, Glycerin, Phenoxyethanol, Propylene Carbonate, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethylhexylglycerin, Polysorbate 20, Sclareolide, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Linalool, Linalyl Acetate, Plankton Extract, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Decyl Glucoside, Sodium Ascorbate, Caprylyl Glycol, Hexylene Glycol, Tocopherol

Packaging

Image (8156810150)

Image (8156810150)

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