Ymlabs
FDA Label NDC 10827-0008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yusef Manufacturing Laboratories for the product Ymlabs (NDC 10827-0008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, warnings, instructions for use, inactive ingredient, other safety information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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>

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

Warnings

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

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

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 Template (Yml 9j000 Rev 7)

Spf30 Flavored Lip Balm Template (Yml 9j000 Rev 7)

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