FDA.reportPublic FDA data

YMLABS

Manufacturer
Yusef Manufacturing Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:37

Label at a glance#

ProductYMLABS
Active ingredientOXYBENZONE, OCTINOXATE
Label structure7 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SPF 15Sunscreen

LIP MOISTURIZER

Drug Factsnet 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: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

SPF15 Flavored Lip Balm TemplateSPF15 Flavored Lip Balm Template

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10827-0004-12024-04-18C16284748780-11030e364-ff14-111a-e063-dadaa90a10e2YMlabs SPF15 Flavored Lip Balm
10827-0004-12024-01-30C16284748780-11030e364-ff14-111a-e063-dadaa90a10e2YMlabs SPF15 Flavored Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10827-0004-1YMLABS4.2 g in 1 TUBESTICK4.24

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
10827-000410827-0004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
CERESINQ1LS2UJO3AIACT
WHITE WAX7G1J5DA97FIACT
MINERAL OILT5L8T28FGPIACT
COCONUT OILQ9L0O73W7LIACT
SACCHARIN CALCIUM5101OP7P2IIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SAFFLOWER OIL65UEH262ISIACT
ALOEV5VD430YW9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
OXYBENZONE95OOS7VE0YACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
YMLABSSPF15 FLAVORED LIP BALMYusef Manufacturing Laboratories6c456df1-db54-481b-b583-186b9bdaf6702026-01-12WarningsExact identifier
ndc (package): 10827-0004-1
ndc (product): 10827-0004
ndc11 (package): 10827000401
spl id: 48364bfe-f96d-5040-e063-6294a90a3503
spl set id: 6c456df1-db54-481b-b583-186b9bdaf670

Reported adverse events (FAERS/openFDA)#

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