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Drug Facts
Lip Balm Spf15( 2533) Lipstick
FDA Label NDC 82953-073
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( 2533) (NDC 82953-073). 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 - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octocrylene 3%
Homosalate 5%
Avobenzone 2%
Octisalate 3%
Purpose
Sunscreen
Uses
Helps prevent sunburn
Warnings
For external use only.
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 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor
Route, Method And Frequency Of Administration
Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sunprotection measures including:*Limit time in the sun, especially from10am to 2 pm.* Wear long sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients
Mineral oil, petrolatum, ozokerite, polyisobutene, ethylhexyl palmitate,beeswax, butyrospermum parkii (shea) butter, microcrystalline wax,phenoxyethanol, fragrance, BHT
Otc - Questions
questions?
Package Label.Principal Display Panel
principal display panel
* Please review the disclaimer below.
