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Distributed by: Glowell, LLC.
South Plainfield, NJ 07080.
Glowell Spf 30 Tinted Mineral Sunscreen
FDA Label NDC 83495-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glowell, Llc. for the product Glowell Spf 30 Tinted Mineral Sunscreen (NDC 83495-101). 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 other, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, 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 |
|---|---|
| Zinc Oxide 14.20% | Sunscreen |
| Titanium Dioxide 0.5% | 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 and ask a doctor if a rash occurs.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 80 minutes of swimming or sweating.
- Immediately after towel drying.
- at least every two 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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am – 2pm.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
Inactive Ingredients
- Deionized Water, Isododecane, C12-15 Alkyl Benzoate, Iron Oxide, Butylene Glycol, Polyglyceryl-3 Diisostearate, Mica, Cocos Nucifera (Coconut) Oil, Quaternium-90 Bentonite, VP/Eicosene Copolymer, Butyrospermum Parkii (Shea) Butter, Polyhydroxystearic Acid, Gluconolactone (and) Sodium Benzoate, Fragrance, Propylene Carbonate, Bismuth Oxychloride, Triethoxycaprylylsilane, Tocopherol, Titanium Dioxide (CI77891), Ethyl Ferulate.
Other Information
- Protect this product from excessive heat and direct sun. Wash with soap to remove from skin.
Questions Or Comments?
Call 1-833-GLOW-SPF
Principal Display Panel - 147 Ml Tube Label - Light
GLO
WELL®
SPF30
TINTED
MINERAL
SUNSCREEN
ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH
FOR
LIGHT SKIN
TONES
UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)
Principal Display Panel (147 mL Tube Label)
Principal Display Panel - 147 Ml Tube Label - Medium
GLO
WELL®
SPF30
TINTED
MINERAL
SUNSCREEN
ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH
FOR
MEDIUM SKIN
TONES
UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)
Principal Display Panel (147 mL Tube Label)
Principal Display Panel - 147 Ml Tube Label - Tan
GLO
WELL®
SPF30
TINTED
MINERAL
SUNSCREEN
ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH
FOR
TAN SKIN
TONES
UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)
Principal Display Panel (147 mL Tube Label)
Principal Display Panel - 147 Ml Tube Label - Deep
GLO
WELL®
SPF30
TINTED
MINERAL
SUNSCREEN
ADAPTS TO SKIN TONE
WITH A BUILDABLE
GLOWING FINISH
FOR
DEEP SKIN
TONES
UVA/UVB BROAD SPECTRUM SPF 30
WATER RESISTANT 80 MINUTES
5FL OZ. (147mL)
Principal Display Panel (147 mL Tube Label)
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