Active Ingredients
Titamiun Dioxide 5.61%
Zinc Oxide 10.08%
Beta-glucan Mild Sunscreen Lotion
FDA Label NDC 83403-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Iunik Co., Ltd for the product Beta-glucan Mild Sunscreen (NDC 83403-101). 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 active ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, beta-glucan mild sunscreen, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children
- If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure.
- Sun protection measures.
- Limit time in the sun, especially from 10 a.m.–2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- 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 skin 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:
Inactive Ingredients
Water, Dimethicone, Butyloctyl Salicylate, Neopentyl Glycol Diheptanoate, Glycerin, Trisiloxane, Silica, Isotridecyl Isononanoate, Trimethylsiloxysilicate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Methyl Trimethicone, Isostearyl Polyglyceryl-3 Dimethicone, Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Magnesium Sulfate, 1,2-Hexanediol, Benzotriazolyl Dodecyl p-Cresol, Triethoxycaprylylsilane, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Caprylyl Glycol, Hydroxypropyl Bispalmitamide MEA, Butylene Glycol, Pinus Densiflora Leaf Extract, Hydrogenated Lecithin, Bacillus Ferment, Cetearyl Alcohol, Beta-Glucan, Scutellaria Baicalensis Root Extract, Tremella Fuciformis Polysaccharide, Centella Asiatica Extract, Ceramide NP, Ceramide NG, Cholesterol, Phytosphingosine, Papaver Rhoeas Flower Extract, Ceramide AS, Ceramide AP, Ceramide EOP
Beta-Glucan Mild Sunscreen
BETA-GLUCAN MILD SUNSCREEN
* Please review the disclaimer below.
