Byoma Moisturizing Gel Sunscreen Broad Spectrum Spf 30 Cream
FDA Label NDC 14268-123

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Englewood Lab, Inc. for the product Byoma Moisturizing Gel Sunscreen Broad Spectrum Spf 30 (NDC 14268-123). 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 3%,

Homosalate 10%,

Octisalate 5%

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 generously and evenly 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating:
• Reapply at least every 2 hours.
• 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 sunprotection 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

Water (Aqua), Glycerin, Butyloctyl Salicylate, Propanediol, Dimethicone, Beta-Glucan, Sodium Hyaluronate, Caprylhydroxamic Acid, Caprylic/Capric Trilgyceride, Ceramide NP, Cholesterol, Phytosphingosine, Caprylyl Glycol, Dextrin Palmitate, Dibutyl Ethylhexanoyl Glutamide, Stearic Acid, Oleic Acid, DIbutyl Lauroyl Glutamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Lecithin, Eugenia Caryophyllus (Clove) Bud Extract, Hydroxyacetophenone, Lactic Acid, Lecithin, Octyldodecanol, 1,2-Hexanediol, Panthenol, Poly C10-30 Alkyl Acrylate, Pullulan, Sclerotium Gum, Sodium Polyacryloyldimethyl Taurate, Solidago Virgaurea Extract, Tocopherol, Xanthan Gum.

* Please review the disclaimer below.