SPL v4
SPL
SPL Set ID d1a8cfed-4038-4d43-af75-6ad3cbc25768
Route
CUTANEOUS
Published
Effective Date 2025-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1 g)
Inactive Ingredients
Water Cyclopentasiloxane Polymethylsilsesquioxane (4.5 Microns) Betaine Sodium Benzoate Xanthan Gum Jojoba Oil Laureth-7 Cetearyl Olivate Squalane Ethylhexylglycerin Butyrospermum Parkii (shea) Butter Arbutin Acetyl Hexapeptide-8 Sodium Hyaluronate Bakuchiol Charcoal Powder Centella Asiatica Onopordum Acanthium Flower Aloe Barbadensis Leaf Camellia Sinensis Leaf Matricaria Chamomilla Flowering Top Glycyrrhiza Glabra (licorice) Root Rosmarinus Officinalis (rosemary) Leaf Powder Aristotelia Chilensis Fruit Aronia Melanocarpa Fruit Euterpe Oleracea Fruit Oil Garcinia Mangostana Fruit Lycium Barbarum Fruit Morinda Citrifolia Fruit Punica Granatum Fruit Juice Vaccinium Myrtillus Fruit Juice Marine Collagen, Soluble Caffeine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-15

Description

GLYCERIN


Medication Information

Indications and Usage

Product Name:

HYDRASPHERE+ HydroCharcoal Silk mask

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively. Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.

Dosage and Administration

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively. Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.

Description

GLYCERIN

Active

GLYCERIN

Section 43683-2

Section 50567-7

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively. Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.

Section 51945-4

HydroCharcoal Silk maskCharcoal Therapy

Developed with bioengineered delivery systems, this leave-onmask combines activated charcoal microparticles with encapsulatedhyaluronic acid and signal peptides to target the visible signs ofaging at the surface level, The formula works to smooth theappearance of fine lines and wrinkles, enhsnce skin density, andpromote a more even, radiant tone.

Clinically inspired and powered by antioxidant-rich botanicals, itprovides multi-layer hydration and supports skin's natural renewalprocess-without the need to rinse.

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively.Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.Ingredients:

Polysilicone-ll, Aqua (Water),Cyclopentasiloxane, Polymethylsilsesquioxane, Glycerin,Betaine,Sodium Benzoate,Xanthan Gum, Jojoba Oil, Laureth-7, Cetearyl Olivate,Squalane, Ethylhexylglycerin, Butyrospermum Parkii (Shea) Butter, Arbutin, AcetylHexapeptide-8, Sodium Hyaluronate, Bakuchiol, Charcoal,Tocopheryl Acetate, CentellaAsiatica Extract, Onopordum Acanthium Flower/Leaf/Stem Extract, Aloe BarbadensisLeaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Chamomila Recutita (Matricaria)Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis(Rosemary) Leaf Extract, Aristotelia Chilensis (Maqui) Fruit Extract, Aronia Melanocarpa(Chokeberry) Fruit Extract, Euterpe Oleracea(Acai Berry) F?it Extract, GarciniaMangostana (Mangosteen) Fruit Extract, Lycium Barbarum (Goji) Fruit Extract, MorindaCitrifolia (Noni) Fruit Extract, Punica Granatum(Pomegranate) Fruit Extract, Vaccinium

Myrtillus (Bilberry) Fruit Extract, Soluble Collagen, Caffeine

Manufactured exclusively byHydrasphere+Miami, FL, USAwww.hydrasphereplus.com

Section 55105-1

Developed with bioengineered delivery systems, this leave-onmask combines activated charcoal microparticles with encapsulatedhyaluronic acid and signal peptides to target the visible signs ofaging at the surface level, The formula works to smooth theappearance of fine lines and wrinkles, enhance skin density, andpromote a more even,radiant tone.

Warnings

For external use only. Avoid contact with eyes. Discontinue use if irritation occurs.Keep out of reach of children. lf swallowed, get medical help or contact a PoisonControl Center right away.

Inactive

Polysilicone-ll, Aqua (Water), Cyclopentasiloxane, Polymethylsilsesquioxane, GlycerinBetaine, Sodium Benzoate,Xanthan Gum, Jojoba Oil, Laureth-7,Cetearyl Olivate,Squalane, Ethylhexyl glycerin, Butyrospermum Parkii (Shea) Butter, Arbutin, AcetylHexapeptide-8, Sodium Hyaluronate, Bakuchiol, Charcoal,Tocopheryl Acetate, CentellaAsiatica Extract, Onopordum Acanthium Flower/Leaf/Stem Extract, Aloe BarbadensisLeaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria)Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis(Rosemary) Leaf Extract, Aristotelia Chilensis (Maqui) Fruit Extract, Aronia Melanocarpa(Chokeberry) Fruit Extract, Euterpe Oleracea (Acai Berry) Fruit Extract, GarciniaMangostana (Mangosteen) Fruit Extract, Lycium Barbarum (Goji) Fruit Extract, MorindaCitrifolia (Noni) Fruit Extract, Punica Granatum(Pomegranate) Fruit Extract, Vaccinium

Myrtillus (Bilberry) Fruit Extract, Soluble Collagen, Caffeine

Pregautions:

Keep out of reach of children. lfswallowed, get medical help or contact a Poison

Control Center right away.


Structured Label Content

Active (active)

GLYCERIN

Indications and Usage (34067-9)

Product Name:

HYDRASPHERE+ HydroCharcoal Silk mask

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively. Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.

Dosage and Administration (34068-7)

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively. Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.

Section 43683-2 (43683-2)

Section 50567-7 (50567-7)

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively. Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.

Section 51945-4 (51945-4)

HydroCharcoal Silk maskCharcoal Therapy

Developed with bioengineered delivery systems, this leave-onmask combines activated charcoal microparticles with encapsulatedhyaluronic acid and signal peptides to target the visible signs ofaging at the surface level, The formula works to smooth theappearance of fine lines and wrinkles, enhsnce skin density, andpromote a more even, radiant tone.

Clinically inspired and powered by antioxidant-rich botanicals, itprovides multi-layer hydration and supports skin's natural renewalprocess-without the need to rinse.

Apply a thin, even layer to clean, dry skin, focusing on areas withfine lines or wrinkles. Gently pat and smooth until fully absorbed.Do not rub aggressively.Avoid facial movement for 2-3 minutes toallow the formula to set. For optimal results, use once or twice aweek or before special occasions.Ingredients:

Polysilicone-ll, Aqua (Water),Cyclopentasiloxane, Polymethylsilsesquioxane, Glycerin,Betaine,Sodium Benzoate,Xanthan Gum, Jojoba Oil, Laureth-7, Cetearyl Olivate,Squalane, Ethylhexylglycerin, Butyrospermum Parkii (Shea) Butter, Arbutin, AcetylHexapeptide-8, Sodium Hyaluronate, Bakuchiol, Charcoal,Tocopheryl Acetate, CentellaAsiatica Extract, Onopordum Acanthium Flower/Leaf/Stem Extract, Aloe BarbadensisLeaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Chamomila Recutita (Matricaria)Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis(Rosemary) Leaf Extract, Aristotelia Chilensis (Maqui) Fruit Extract, Aronia Melanocarpa(Chokeberry) Fruit Extract, Euterpe Oleracea(Acai Berry) F?it Extract, GarciniaMangostana (Mangosteen) Fruit Extract, Lycium Barbarum (Goji) Fruit Extract, MorindaCitrifolia (Noni) Fruit Extract, Punica Granatum(Pomegranate) Fruit Extract, Vaccinium

Myrtillus (Bilberry) Fruit Extract, Soluble Collagen, Caffeine

Manufactured exclusively byHydrasphere+Miami, FL, USAwww.hydrasphereplus.com

Section 55105-1 (55105-1)

Developed with bioengineered delivery systems, this leave-onmask combines activated charcoal microparticles with encapsulatedhyaluronic acid and signal peptides to target the visible signs ofaging at the surface level, The formula works to smooth theappearance of fine lines and wrinkles, enhance skin density, andpromote a more even,radiant tone.

Warnings (WARNINGS)

For external use only. Avoid contact with eyes. Discontinue use if irritation occurs.Keep out of reach of children. lf swallowed, get medical help or contact a PoisonControl Center right away.

Inactive (inactive)

Polysilicone-ll, Aqua (Water), Cyclopentasiloxane, Polymethylsilsesquioxane, GlycerinBetaine, Sodium Benzoate,Xanthan Gum, Jojoba Oil, Laureth-7,Cetearyl Olivate,Squalane, Ethylhexyl glycerin, Butyrospermum Parkii (Shea) Butter, Arbutin, AcetylHexapeptide-8, Sodium Hyaluronate, Bakuchiol, Charcoal,Tocopheryl Acetate, CentellaAsiatica Extract, Onopordum Acanthium Flower/Leaf/Stem Extract, Aloe BarbadensisLeaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria)Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis(Rosemary) Leaf Extract, Aristotelia Chilensis (Maqui) Fruit Extract, Aronia Melanocarpa(Chokeberry) Fruit Extract, Euterpe Oleracea (Acai Berry) Fruit Extract, GarciniaMangostana (Mangosteen) Fruit Extract, Lycium Barbarum (Goji) Fruit Extract, MorindaCitrifolia (Noni) Fruit Extract, Punica Granatum(Pomegranate) Fruit Extract, Vaccinium

Myrtillus (Bilberry) Fruit Extract, Soluble Collagen, Caffeine

Pregautions: (PREGAUTIONS:)

Keep out of reach of children. lfswallowed, get medical help or contact a Poison

Control Center right away.


Advanced Ingredient Data


Raw Label Data

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