Active Ingredients
Avobenzone 3%,
Homosalate 10%,
Octisalate 5%
Byoma Moisturizing Sunscreen Spf 30 Gel
FDA Label NDC 84821-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Byoma Limited for the product Byoma Moisturizing Sunscreen Spf 30 (NDC 84821-001). 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, when using this product, do not use, stop use and ask a doctor, 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
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- If used as directed wtih other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.
Warnings
For external use only
When Using This Product
keep out of eyes. Rinse with water to remove.
Do Not Use
on damaged or broken skin.
Stop Use And Ask A Doctor
if rash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
- Apply generously and evenly 15 minutes before sun exposure.
- Use a water resistant sunscreen if swiming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months of age: 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 a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sunprotection measures including
- Limit time in the sun, especially from 10am-2pm
- Wear long sleeved shirts, pants, hats and sunglasses.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water (Aqua), Glycerin, Butyloctyl Salicylate, Propanediol, Dimethicone, Beta-Glucan, Sodium Hyaluronate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Ceramide NP, Cholesterol, Phytosphingosine, Caprylyl Glycol, Dextrin Palmitate, Dibutyl Ethylhexanoyl Glutamide, Stearic Acid, Oleic Acid, Dibutyl Lauroyl Glutamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Lecithin, Eugenia Caryophyllus (Clove) Bud Extract, Hydroxyacetophenone, Lactic Acid, Lecithin, Octyldodecanol, 1,2-Hexanediol, Panthenol, Poly C10-30 Alkyl Acrylate, Pullulan, Sclerotium Gum, Sodium Polyacryloyldimethyl Taurate, Solidago Virgaurea Extract, Tocopherol, Xanthan Gum.
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Product Packaging
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