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#
Contacts and useful links#
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10827-0008-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5ea5-111a-e063-dadaa90a10e2 | YMlabs SPF30 Flavored Lip Balm |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10827-0008-1 | YMLABS | 4.2 g in 1 TUBE | STICK | 4.2 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10827-0008 | YMLABS (SPF30 FLAVORED LIP BALM) STICK [YUSEF MANUFACTURING LABORATORIES] | 1 | Legacy NDC, 1 package rows | 20220126_739fcb06-e32c-42a3-98a8-7eab8faab219.zip |
Products#
Every source-derived product name is available through these pages.
- YMLABS
- SPF30 FLAVORED LIP BALM
- MERADIMATE
- OCTINOXATE
- OCTISALATE
- OXYBENZONE
- PETROLATUM
- CERESIN
- WHITE WAX
- MINERAL OIL
- COCONUT OIL
- SACCHARIN
- ALPHA-TOCOPHEROL ACETATE
- PHENYL TRIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10827-0008 | 10827-0008-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MERADIMATE | J9QGD60OUZ | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| CERESIN | Q1LS2UJO3A | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| SACCHARIN | FST467XS7D | IACT |
| ALPHA-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| PHENYL TRIMETHICONE | DR0K5NOJ4R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5e061b0b-dead-475d-a304-51d34afc6c2d | 739fcb06-e32c-42a3-98a8-7eab8faab219 | 2022-01-25 | Warnings | 5e061b0b-dead-475d-a304-51d34afc6c2d 739fcb06-e32c-42a3-98a8-7eab8faab219 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
