Brushonblock Mineral Powder Sunscreen Broad Spectrum Spf30 Translucent Cream
FDA Label NDC 84255-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Brownkind Dermascience Inc. for the product Brushonblock Mineral Powder Sunscreen Broad Spectrum Spf30 Translucent (NDC 84255-000). 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, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 2.5%

Octinoxate 7.5%

Octisalate 5%

Octocrylene 1%

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating. 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 10AM-2PM
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: ask a doctor.

Other Information

Protect the product in this container from excessive heat and direct sunlight.

Inactive Ingredients

Water, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Glyceryl Stearate, Diethylhexyl 2,6-Naphthalate, Ceteareth-20, Calcium Sodium Borosilicate, Butyl Methoxydibenzoylmethane, Niacinamide, Glycerin, Butylene Glycol, PEG-10 Stearate, Magnesium Aluminum Silicate, Cetearyl Alcohol, VP/Hexadecene Copolymer, Phenoxyethanol, Propanediol, Polymethylsilsesquioxane, Dimethicone, Isohexadecane, Xanthan Gum, Octyldodecanol, Glyceryl Stearate SE, Cetearyl Methicone, PEG-40 Stearate, Steareth-2, Steareth-21,Ethylhexylglycerin, Disodium EDTA, Amla (Phyllanthus Emblica) Fruit Extract, BHT, Rainbow Algae (Cystoseira Tamariscifolia) Extract, Cocoa (Theobroma Cacao) Extract, Lecithin, Tocopherol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Sodium Benzoate 

Questions?

1(800) 687-7165

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