Gleam + Glow Spf 50.

Gleam + Glow Spf 50.
SPL v2
SPL
SPL Set ID 3e392af6-1401-4a2f-9ba4-e43f0fd0fca1
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 Ceramide Np Ceramide Ap Ceramide 9 Phytosphingosine Allantoin Panthenol Rosemary Niacinamide Tremella Fuciformis Fruiting Body Vitis Vinifera Seed Macadamia Oil Olive Oil Sesame Oil Lavender Oil Caffeine Diatomaceous Earth Green Tea Leaf Hyaluronate Sodium Sodium Ascorbyl Phosphate Acetyl Hexapeptide-8 Aloe Vera Leaf Chamomile Laminaria Digitata Tea Tree Oil Rosa Moschata Seed Oil Medium-chain Triglycerides Sodium Polyacrylate (8000 Mw) Tert-butylhydroquinone Phenylpropanol Hydrogenated Soybean Lecithin Sodium Hydroxide Teprenone Proline Sorbitol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Caprylhydroxamic Acid Ethylhexylglycerin Xanthan Gum Cholesterol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Sodium Lauroyl Lactylate

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 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


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 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 (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


Advanced Ingredient Data


Raw Label Data

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