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Drug Facts
Lip Balm Spf15( Cb400) Lipstick
FDA Label NDC 82953-042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmuses Cosmetics (ningbo) Co., Ltd. for the product Lip Balm Spf15( Cb400) (NDC 82953-042). 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, active ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octocrylene 8%
Octisalate 4%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months of age: Ask a doctor.
Inactive Ingredients
Beeswax, Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Tocopherol, Phenoxyethanol, Fragrance
Other Information
Protect from excessive heat and direct sun.
* Please review the disclaimer below.
