Otc - Active Ingredient
Zinc Oxide 4.85%
Titanium Dioxide 8%
Spf 50 Mineral Sunscreen Lip Cream
FDA Label NDC 84066-104
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 Spf 50 Mineral Sunscreen Lip (NDC 84066-104). 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
Helps prevent sunburn.
if used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin agingcaused by the sun.
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.lf swallowed, getmedical help or contact Posion Center right away.
Dosage & Administration
Directions
·Applyliberally15 minutes before sun exposure·Reapply:·after 80 minutes of swimming orsweating·after towel drying, swimming, or·at least every 2 hours ·children under 6 months of age: ask a doctor.
Other Safety Information
.Protect this product from excessive heat and direct sun.Sun alert: Limiting sunexposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects ofthe sun.
Inactive Ingredient
Water,Dimethicone, lsohexadecane, EthylhexylPalmitate, Butylene Glycol, Glycerin, lsopropyl PalmitateSorbitan Sesquioleate, Cetyl Peg/Ppg-10/ Dimethicone.Silica, Disteardimonium Hectorite, Sodium Chloride,Trimethylsiloxysilicate, Peg-30 Dipolyhydroxystearate,
Tribehenin, Magnesium Stearate, Phenoxyethanol,Triethoxycaprylylsilane Ethylhexylglycerin, PentaerythrityTetra-Di-T-Buty Hydroxyhydrocinnamate
Otc - Questions
Please call:1-817-398-8817 or emus at [email protected].
* Please review the disclaimer below.
