Otc - Active Ingredient
Ethylhexyl Methoxycinnamate 7.5%
Octocrylene 5%
Sunscreen Lip Protectionbroad Spectrum Spf 15 Gel
FDA Label NDC 84066-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Tata Biotechnology Co., Ltd. for the product Sunscreen Lip Protectionbroad Spectrum Spf 15 (NDC 84066-103). 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 - stop use, 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
Otc - Purpose
Sunscreen
Indications & Usage
protect lips from damaging UVA and UVB rays.
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 - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Step 1:Saueeze tube.
Step 2:Apply liberally and evenly to lips 15 to 20 minutes before exposure to the sun.
Step3:Reapply after periods of swimming exercise and towel drying or as required.
Other Safety Information
Protect this product from excessive heat anddirect sun.
Sun alert: Limiting sun exposure, wearing protective clothing,and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects of the sun.
Inactive Ingredient
Ethylhexyl Palmitate, Polyisobutene,Petrolatum,Microcrystalline Wax,Hydrogenated Styrene/lsoprene Copolymer,PentaerythritylTetra-Di-T-ButylHydroxyhydrocinnamate,Beeswax, Synthetic Wax, Tocopheryl Acetate, Tridecyl Trimellitate,Simmondsia Chinensis (Jojoba) Seed Oil,Macadamia Integrifolia Seed Oil, Limnanthes Alba(Meadowfoam)Seed Oi,Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil,Phenoxyethanol,Ethylhexylglycerin,Fragrance,FD&C YELLOW NO.5(C119140),TheobromaCacao(Cocoa)Extract,
Dextrin,Phytosteryl/OctyldodecylLauroyl, Glutamate,Tocopherol
Otc - Questions
You can email us at [email protected] for more help!
* Please review the disclaimer below.
