Otc - Active Ingredient
Active Ingredients
Zinc Oxide 17%
Round Lab Birch Juice Mild-up Uvlock Sunscreen Spf50 Broad Spectrum Cream
FDA Label NDC 84616-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Seorin Company Co., Ltd. for the product Round Lab Birch Juice Mild-up Uvlock Sunscreen Spf50 Broad Spectrum (NDC 84616-002). 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
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 - 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 swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- apply liberally and evenly 15 minutes before sun exposure.
- Sun protection measures.
- children under 6 months of age: Ask a doctor
- reapply at least every 2 hours.
- use a water-resistant sunscreen if swimming or sweating
Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses
Other
Other Information
- protect the product from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients
Water, Cyclohexasiloxane, Butyloctyl Salicylate, Propanediol, Propylheptyl Caprylate, Isododecane, Caprylyl Methicone, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylysilane, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Lauryl Polyglyceryl-3 Polydimethyisiloxyethyl Dimethicone, Butylene Glycol, Betula Platyphylla Japonica Juice, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexy glycerin, Artemisia Ánnua Extract, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Pinus Sylvestris Leaf Oil, Glycerin, Nelumbo Nucifera Leaf Extract, Cryptomeria Japonica Leaf Extract, Saccharomyces Ferment Filtrate, Tocopherol, Glyceryl Glucoside, Hyaluronic Acid, Ascorbic Acid
Otc - Questions
Questions or comments?
www.roundlab.com
Package Label.Principal Display Panel
BIRCH JUICE
MILD-UP UVLOCK
SUNSCREEN
SPF50+ Broad spectrum
ROUND LAB
50nL 1.69fl. oz.
* Please review the disclaimer below.
