Dermaka Broad Spectrum Spf-42 Sunscreen Untinted Cream
FDA Label NDC 82240-424

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermaka Skin Products for the product Dermaka Broad Spectrum Spf-42 Sunscreen Untinted (NDC 82240-424). 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

Titanium dioxide 6.00%

Zinc Oxide 11.00%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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 onlynot intended for ingestion.

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 or irritation develops and lasts.

Consult your doctor before use if 

Pregnant Or Breastfeeding.

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.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a 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:

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

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Citric Acid, Chamomilla Recutita (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Gleceryl Stearate, Glyceryl Undecylenate, Glyyrrhiza Glabra (Licorice) Extract, Hawthorn Exract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, Sambucus Nigra (Elderberry)Extract, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Questions?

(772) 266-3376

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