Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30

Manufacturer
ENGLEWOOD LAB, INC.
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:09

Label at a glance#

ProductByoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure8 sections

Indications and 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.

Dosage and administration

• 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. • 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 i...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%,

Homosalate 10%,

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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. • 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.




Sun Protection Measures 

Other information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

Questions or Comments?

OTC - QUESTIONS SECTION

contact hello@byoma.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14268-123-01Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 3050 mL in 1 BOTTLECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14268-123BYOMA MOISTURIZING GEL SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [ENGLEWOOD LAB, INC.]3Current NDC, 1 package rows20231213_f63fe60f-9863-1dfb-e053-2a95a90a90a5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14268-12314268-123-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEENGLEWOOD LAB, INC.f63fe60f-9863-1dfb-e053-2a95a90a90a52023-12-12WarningsExact identifier
ndc (package): 14268-123-01
ndc (product): 14268-123
ndc11 (package): 14268012301
spl id: 0c5b602d-b985-ffad-e063-6294a90a4eee
spl set id: f63fe60f-9863-1dfb-e053-2a95a90a90a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.