FDA.reportPublic FDA data

YMLABS

Manufacturer
Yusef Manufacturing Laboratories
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:47:25

Label at a glance#

ProductYMLABS
Active ingredientOXYBENZONE, OCTINOXATE
Label structure7 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SPF 15 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.

<INSERT FLAVOR>

BEESWAX LIP MOISTURIZER

Drug Facts net wt 4.2g
Active Ingredients        Purpose
Octinoxate (7%).............Sunscreen
Oxybenzone (4%)...........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: Beeswax, Cocos Nucifera
(Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil,
Tocopherol, Tocopheryl Acetate, Carthamus Tinctorius
(Safflower) Seed Oil (and) Aloe Barbadenis Leaf Extract.

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

YML BEESWAX SPF15 FLAVORED LIP BALMYML BEESWAX SPF15 FLAVORED LIP BALM

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10827-0006-12024-01-30C16284748780-11030e365-0e90-111a-e063-dadaa90a10e2YMlabs SPF15 Beeswax Flavored Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10827-0006-1YMLABS4.2 g in 1 TUBESTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10827-0006YMLABS (SPF15 BEESWAX FLAVORED LIP BALM) STICK [YUSEF MANUFACTURING LABORATORIES]1Legacy NDC, 1 package rows20220123_a89ba580-48d1-4d4f-abdb-c603a1c6e8b3.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10827-000610827-0006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBENZONE95OOS7VE0YACTIB
OCTINOXATE4Y5P7MUD51ACTIB
WHITE WAX7G1J5DA97FIACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SAFFLOWER OIL65UEH262ISIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
25f9c804-6591-4d69-ac97-bfb1398b348aa89ba580-48d1-4d4f-abdb-c603a1c6e8b32022-01-21WarningsExact identifier
spl id: 25f9c804-6591-4d69-ac97-bfb1398b348a
spl set id: a89ba580-48d1-4d4f-abdb-c603a1c6e8b3

Reported adverse events (FAERS/openFDA)#

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