YMLABS

Manufacturer
Yusef Manufacturing Laboratories
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:47:34

Label at a glance#

ProductYMLABS
Active ingredientMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure7 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SPF 30 Sunscreen

Uses: Helps prevent sunburn.
Directions: Apply evenly, 15
minutes before sun exposure.
Other: Protect this product from
excessive heat & direct sun.
Warnings: For external use only.
Children under 6 months: Ask a
doctor.

Drug Facts net wt 4.2g
Active Ingredients        Purpose

Meradimate (5%)...........Sunscreen

Octinoxate (7.5%).............Sunscreen

Octisalate (5%)..............Sunscreen
Oxybenzone (5%)...........Sunscreen

Made in the USA

Distributed by
<Vendor, City, ST>

SPL UNCLASSIFIED SECTION

Drug Facts (continued)
Uses: • Helps prevent sunburn • Higher SPF gives
more sunburn protection.

WARNINGS SECTION

Warnings: For external use only. 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.

INSTRUCTIONS FOR USE SECTION

Directions: • Apply evenly 15 minutes before sun
exposure and as needed • Reapply at least every 2
hours • Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Petrolatum, Ozokerite,
Beeswax, Mineral Oil, Coconut Oil, Flavor, Saccharin,
Phenyl Trimethicone, Safflower Seed Oil, Aloe Oil,
Vitamin E Acetate

OTHER SAFETY INFORMATION

Other Information: Moderate sun protection product
• Sun Alert: Limiting sun exposure, wearing protective
clothing, and using sunscreens may reduce the risks of
skin aging, skin cancer, and other harmful effects of the
sun.
Questions? 877.827.5425

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF30 Flavored Lip Balm TemplateSPF30 Flavored Lip Balm Template

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10827-0008-12024-01-30C16284748780-11030e365-5ea5-111a-e063-dadaa90a10e2YMlabs SPF30 Flavored Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10827-0008-1YMLABS4.2 g in 1 TUBESTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10827-0008YMLABS (SPF30 FLAVORED LIP BALM) STICK [YUSEF MANUFACTURING LABORATORIES]1Legacy NDC, 1 package rows20220126_739fcb06-e32c-42a3-98a8-7eab8faab219.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10827-000810827-0008-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
5e061b0b-dead-475d-a304-51d34afc6c2d739fcb06-e32c-42a3-98a8-7eab8faab2192022-01-25WarningsExact identifier
spl id: 5e061b0b-dead-475d-a304-51d34afc6c2d
spl set id: 739fcb06-e32c-42a3-98a8-7eab8faab219

Reported adverse events (FAERS/openFDA)#

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