Tint Plus Tone Spf 50. Lotion
FDA Label NDC 49358-582

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 Tint Plus Tone Spf 50. (NDC 49358-582). 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.

Other

Drug Facts

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

Otc - Purpose

Active ingredientsPurpose
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 611, Pompton Plains, NJ 07444

Inactive Ingredients

Water, Butyloctyl Salicylate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Dimethicone, Zea Mays (Corn) Oil, Polyester-8, Coco-Caprylate/Caprate, Polysilicone-15, Sodium Stearoyl Glutamate, Sodium Hyaluronate (Hyaluronic Acid), Panthenol (Vitamin B-5), Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Caffeine, Sodium Ascorbyl Phosphate (Vitamin C), Niacinamide, Vitis Vinifera (Grape) Callus Culture Extract, Camellia Sinensis Leaf Extract (Green Tea), Aloe Barbadensis Leaf Extract (Aloe Vera), Proline, Allantoin, Chamomilla Recutita (Matricaria) Extract, Tremella Fuciformis (Mushroom) Extract, Macadamia Integrifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Rosa Moschata (Rosehip) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Diatomaceous Earth, Laminaria Digitata (Seaweed) Extract, Sesamum Indicum (Sesame) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ferric Hexapeptide-35, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Caprylic/ Capric Triglyceride, Caprylyl Glycol, Sodium Polyacrylate, Teprenone, Lecithin, Sorbitol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Cholesterol, Ethylhexylglycerin, Xanthan Gum, Carbomer, Sodium Hydroxide, TBHQ, Phenylpropanol, 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®

TINT
+
TONE

Broad Spectrum SPF 50
Sheer Tinted Moisturizer

SPF 50

Skin-Refining, Sheer
Tinted Moisturizer; Vitamin C,
Green Tea and Rosehip

DERMATOLOGIST
DEVELOPED

CERAMIDES
CAFFEINE

MUSHROOM EXTRACT
HYLAURONIC ACID

1.7 FL OZ / 50 ML

Principal Display Panel (50 mL Bottle Carton)

Principal Display Panel (50 mL Bottle Carton)

* Please review the disclaimer below.