Active Ingredient
Zinc Oxide 12%
Luminous Defense Spf 50 Lotion
FDA Label NDC 84163-056
14 label sections · Submitted to the FDA by Levels 2 Skin · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Levels 2 Skin for the product Luminous Defense Spf 50 (NDC 84163-056). 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 ingredient, purpose, uses, warnings, do not use, when using this product, 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 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 Poison Control Center right away.
Directions
- Shake well before use
- Apply generously 15 minutes before sun exposure
- Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 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-sleeve shirts, pants, hats and sunglasses
- children under 6 months of age, ask a doctor
Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Jojoba Esters, Caprylic/Capric Triglyceride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Tridecyl Salicylate, Niacinamide, Methylpropanediol, Silica, Bakuchiol, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Chloride, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Stearalkonium Hectorite, Lecithin, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Nylon-12, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.
Other Information
- Protect this product from excessive heat and direct sun
Questions Or Comments?
Contact [email protected]
Company Information
Manufactured For Levels 2 Skin, LLC | Atlanta, GA 30316 | Levels2Skin.com | [email protected]
Product Label
1 (L2s)
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