Tint + Tone Spf 50.

Tint + Tone Spf 50.
SPL v2
SPL
SPL Set ID 51bd8962-e85a-4964-9337-2ded6b7d8ac8
Route
TOPICAL
Published
Effective Date 2023-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene (27.5 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Glycerin Helianthus Annuus Flowering Top Dimethicone Corn Oil Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Cocoyl Caprylocaprate Polysilicone-15 Sodium Stearoyl Glutamate Hyaluronate Sodium Panthenol Ceramide Np Ceramide Ap Ceramide 9 Phytosphingosine Caffeine Sodium Ascorbyl Phosphate Niacinamide Vitis Vinifera Seed Green Tea Leaf Aloe Vera Leaf Proline Allantoin Chamomile Tremella Fuciformis Fruiting Body Macadamia Oil Olive Oil Rosa Moschata Seed Oil Lavender Oil Diatomaceous Earth Laminaria Digitata Sesame Oil Rosemary Acetyl Hexapeptide-8 Tea Tree Oil Medium-chain Triglycerides Caprylyl Glycol Sodium Polyacrylate (8000 Mw) Teprenone Hydrogenated Soybean Lecithin Sorbitol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Caprylhydroxamic Acid Cholesterol Ethylhexylglycerin Xanthan Gum Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Sodium Lauroyl Lactylate Tert-butylhydroquinone Phenylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctorif rash occurs

Section 50567-7

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not useon damaged or broken skin

Section 55105-1
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 2.75% Sunscreen
Warnings

For external use only

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


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctorif rash occurs

Section 50567-7 (50567-7)

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Section 55105-1 (55105-1)
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 2.75% Sunscreen
Warnings

For external use only

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 (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)