Otc - Active Ingredient
Active Ingredients
Avobenzone...........................3.0%
Homosalate...........................10.0%
Octinoxate.............................7.5%
Octisalate..............................5.0%
Lip Renewal Spf 50 Paste
FDA Label NDC 65278-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by June Jacobs Labs, Llc for the product Lip Renewal Spf 50 (NDC 65278-105). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
Warnings
For External use only
Otc - Do Not Use
Do not use on
- damaged or broken skin
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 product is swallowed, get madical help or contact a poison control center right away.
Dosage & Administration
Directions
- Apply liberally and evenly every 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor
- Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use as sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun especially from 10am -2 pm.
- wear long sleeve shirt, pants hats and sunglasses
Inactive Ingredient
Inactive Ingredients
Microcrystalline Wax, Diisostearyl Malate, Glyceryl Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycerin, Vitis Vinifera (Grape) Seed Oil, Flavor (Aroma), Triisostearin, Tocopherol, Squalane, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Allantoin, Water/ Aqua, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hyaluronic Acid, Phenoxyethanol, Limonene, Citral
Other Safety Information
Other Information
- Protect this product from excessive heat and direct sun.
Otc - Questions
Questions or comments?
Call toll free 1-866-JUNEJACOBS
- www.JUNEJACOBS.com
* Please review the disclaimer below.
