Other
Drug Facts
DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838
Gleam Plus Glow Spf 50. Lotion
FDA Label NDC 49358-581
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mdsolarsciences for the product Gleam Plus Glow Spf 50. (NDC 49358-581). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, 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
| Active ingredients | Purpose |
|---|---|
| Avobenzone 3% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Octocrylene 2.75% | 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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
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.
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
- use a water resistant sunscreen if swimming or sweating
- at least every 2 hours
- Children under 6 months: Ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10a.m.-2p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
Shake well. Rub in well.
- Protect the product in this container from excessive heat and direct sunlight
- May stain some fabrics
- You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients
Water (Aqua), Butyloctyl Salicylate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Dimethicone, Zea Mays (Corn) Oil, Polyester-8, Coco-Caprylate/Caprate, Polysilicone-15, Sodium Stearoyl Glutamate, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Allantoin, Panthenol (Vitamin B5), Rosmarinus Officinalis (Rosemary) Leaf Extract, Niacinamide, Tremella Fuciformis (Mushroom) Extract, Vitis Vinifera (Grape) Callus Culture Extract, Macadamia Integrifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Sesamum Indicum (Sesame Seed Oil), Lavandula Angustifolia (Lavender) Oil, Caffeine, Diatomaceous Earth, Camellia Sinensis Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Sodium Ascorbyl Phosphate, (Vitamin C), Ferric Hexapeptide-35, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Extract, Laminaria Digitata Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosa Moschata Seed Oil, Caprylic/Capric Triglyceride, Sodium Polyacrylate, TBHQ, Phenylpropanol Lecithin, Sodium Hydroxide, Teprenone, Proline, Sorbitol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Ethylhexylglycerin, Xanthan Gum, Cholesterol, Carbomer, Sodium Lauroyl Lactylate, May Contain: Synthetic Fluorphlogopite, CI 77891, CI 77499, CI 77492, CI 77491, CI 77861, CI 77019
Principal Display Panel - 50 Ml Bottle Carton
MDSOLARSCIENCES®
GLEAM
+
GLOW
Broad Spectrum SPF 50
Sheer Glow Tint
SPF
50
Daily Radiance Moisturizer
Antioxidants + Ceramides
DERMATOLOGIST
DEVELOPED
VITAMIN B5
GREEN TEA
NIACINAMIDE
VITAMIN C
1.7 FL OZ / 50 ML
Principal Display Panel (50 ML Bottle Carton)
* Please review the disclaimer below.
