SPL v5
SPL
SPL Set ID 33e7eeb9-70ba-5bfa-e063-6394a90afb78
Route
CUTANEOUS
Published
Effective Date 2025-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Retinol (1 g)
Inactive Ingredients
Sodium Silicate Water Magnesium Aluminum Silicate Sodium Polystyrene Sulfonate Cucumber Fruit Oil Rhodiola Rosea Root Xanthan Gum Caprylic/capric Triglyceride Sodium Hyaluronate Avocado Oil Coffea Arabica Fruit Tuber Magnatum Whole Saccharomyces Cerevisiae Hesperidin Methyl Chalcone Acetyl Hexapeptide-8 Hyaluronic Acid Dipeptide Diaminobutyroyl Benzylamide Diacetate Tremella Fuciformis Whole Dimethylaminoethanol Tartrate Retinyl Palmitate Dipeptide-2 Palmitoyl Tetrapeptide-7 Mica Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-15

Description

RETINOL

Purpose

Anti-Wrinkle Correction & Prevention – Formulated through rigorous scientific research and clinical testing, this advanced cream is designed to address the most common concerns of deep lines and wrinkles in the targeted area: wrinkles, fine lines, puffiness, and dark circles. Using a combination of high-performance ingredients—Hyaluronic Acid, Retinol, Stem Cells, and Peptides—this treatment provides an effective solution for visibly healthier, younger-looking skin.

Warnings and Precautions

Keep out of reach of children.For external use only.Avoid contact with eyes ormucous membranes.Perform a patch test before firstuse. lf irritation occurs,discontinue use.May increase sun sensitivityuse SPF.


Medication Information

Warnings and Precautions

Keep out of reach of children.For external use only.Avoid contact with eyes ormucous membranes.Perform a patch test before firstuse. lf irritation occurs,discontinue use.May increase sun sensitivityuse SPF.

Purpose

Anti-Wrinkle Correction & Prevention –

Formulated through rigorous scientific research and clinical testing, this advanced cream is designed to address the most common concerns of deep lines and wrinkles in the targeted area: wrinkles, fine lines, puffiness, and dark circles. Using a combination of high-performance ingredients—Hyaluronic Acid, Retinol, Stem Cells, and Peptides—this treatment provides an effective solution for visibly healthier, younger-looking skin.

Description

RETINOL

Active

RETINOL

Section 43683-2

Section 51945-4

Product Name:

HYDRASPHERE+ Anti Wrinkle Correction & Prevention

Description:

Anti-Wrinkle Correction & Prevention –

Formulated through rigorous scientific research and clinical testing, this advanced cream is designed to address the most common concerns of deep lines and wrinkles in the targeted area: wrinkles, fine lines, puffiness, and dark circles. Using a combination of high-performance ingredients—Hyaluronic Acid, Retinol, Stem Cells, and Peptides—this treatment provides an effective solution for visibly healthier, younger-looking skin.

Directions for Use:

Apply directly to deep facial lines and wrinkles in the targeted area. Avoid direct contact with the eye. In the event of excess product application, gently remove using a cotton swab.

Ingredients:

Water

Sodium Silicate

Magnesium Aluminum Silicate

Sodium Polystyrene Sulfonate

Cucumber Fruit Extract

Rhodiola Rosea Root Extract

Xanthan Gum

Caprylic/Capric Triglyceride

Sodium Hyaluronate

Avocado Oil

Coffea Arabica Extract

Tuber Magnatum Extract

Saccharomyces Cerevisiae Extract

Hesperidin Methyl Chalcone

Acetyl Hexapeptide-8

Hyaluronic Acid

Dipeptide Diaminobutyroyl Benzylamide Diacetate

Tremella Fuciformis Polysaccharide

Xanthan Gum

Retinol

Dimethylaminoethanol Tartrate

Retinyl Palmitate

Tocopheryl Acetate

Dipeptide-2

Palmitoyl Tetrapeptide-7

Mica

Titanium Dioxide

Inactive

Water

Magnesium Aluminum Silicate

Sodium Polystyrene Sulfonate

Cucumber Fruit Extract

Rhodiola Rosea Root Extract

Xanthan Gum

Caprylic/Capric Triglyceride

Sodium Hyaluronate

Avocado Oil

Coffea Arabica Extract

Tuber Magnatum Extract

Saccharomyces Cerevisiae Extract

Hesperidin Methyl Chalcone

Sodium Silicate

Hyaluronic Acid

Dipeptide Diaminobutyroyl Benzylamide Diacetate

Tremella Fuciformis Polysaccharide

Xanthan Gum

ACETYL HEXAPEPTIDE-8

Dimethylaminoethanol Tartrate

Retinyl Palmitate

Tocopheryl Acetate

Dipeptide-2

Palmitoyl Tetrapeptide-7

Mica

Titanium Dioxide

Pregautions:

Avoid contact with eyes ormucous membranes.

Directions for Use:

Apply directly to deep facial lines and wrinkles in the targeted area. Avoid direct contact with the eye. In the event of excess product application, gently remove using a cotton swab.

Warnings G Pregautions

Perform a patch test before firstuse. lf irritation occurs,discontinue use.

Warnings G Pregautions:

Keep out of reach of children.

Warnings and Precautions:

Keep out of reach of children.For external use only.Avoid contact with eyes ormucous membranes.Perform a patch test before firstuse. lf irritation occurs,discontinue use.May increase sun sensitivityuse SPF.


Structured Label Content

Active (active)

RETINOL

Section 43683-2 (43683-2)

Section 51945-4 (51945-4)

Product Name:

HYDRASPHERE+ Anti Wrinkle Correction & Prevention

Description:

Anti-Wrinkle Correction & Prevention –

Formulated through rigorous scientific research and clinical testing, this advanced cream is designed to address the most common concerns of deep lines and wrinkles in the targeted area: wrinkles, fine lines, puffiness, and dark circles. Using a combination of high-performance ingredients—Hyaluronic Acid, Retinol, Stem Cells, and Peptides—this treatment provides an effective solution for visibly healthier, younger-looking skin.

Directions for Use:

Apply directly to deep facial lines and wrinkles in the targeted area. Avoid direct contact with the eye. In the event of excess product application, gently remove using a cotton swab.

Ingredients:

Water

Sodium Silicate

Magnesium Aluminum Silicate

Sodium Polystyrene Sulfonate

Cucumber Fruit Extract

Rhodiola Rosea Root Extract

Xanthan Gum

Caprylic/Capric Triglyceride

Sodium Hyaluronate

Avocado Oil

Coffea Arabica Extract

Tuber Magnatum Extract

Saccharomyces Cerevisiae Extract

Hesperidin Methyl Chalcone

Acetyl Hexapeptide-8

Hyaluronic Acid

Dipeptide Diaminobutyroyl Benzylamide Diacetate

Tremella Fuciformis Polysaccharide

Xanthan Gum

Retinol

Dimethylaminoethanol Tartrate

Retinyl Palmitate

Tocopheryl Acetate

Dipeptide-2

Palmitoyl Tetrapeptide-7

Mica

Titanium Dioxide

Purpose (PURPOSE)

Anti-Wrinkle Correction & Prevention –

Formulated through rigorous scientific research and clinical testing, this advanced cream is designed to address the most common concerns of deep lines and wrinkles in the targeted area: wrinkles, fine lines, puffiness, and dark circles. Using a combination of high-performance ingredients—Hyaluronic Acid, Retinol, Stem Cells, and Peptides—this treatment provides an effective solution for visibly healthier, younger-looking skin.

Inactive (inactive)

Water

Magnesium Aluminum Silicate

Sodium Polystyrene Sulfonate

Cucumber Fruit Extract

Rhodiola Rosea Root Extract

Xanthan Gum

Caprylic/Capric Triglyceride

Sodium Hyaluronate

Avocado Oil

Coffea Arabica Extract

Tuber Magnatum Extract

Saccharomyces Cerevisiae Extract

Hesperidin Methyl Chalcone

Sodium Silicate

Hyaluronic Acid

Dipeptide Diaminobutyroyl Benzylamide Diacetate

Tremella Fuciformis Polysaccharide

Xanthan Gum

ACETYL HEXAPEPTIDE-8

Dimethylaminoethanol Tartrate

Retinyl Palmitate

Tocopheryl Acetate

Dipeptide-2

Palmitoyl Tetrapeptide-7

Mica

Titanium Dioxide

Pregautions: (PREGAUTIONS:)

Avoid contact with eyes ormucous membranes.

Directions for Use:

Apply directly to deep facial lines and wrinkles in the targeted area. Avoid direct contact with the eye. In the event of excess product application, gently remove using a cotton swab.

Warnings G Pregautions (WARNINGS G PREGAUTIONS)

Perform a patch test before firstuse. lf irritation occurs,discontinue use.

Warnings G Pregautions: (WARNINGS G PREGAUTIONS:)

Keep out of reach of children.

Warnings and Precautions: (WARNINGS and PRECAUTIONS:)

Keep out of reach of children.For external use only.Avoid contact with eyes ormucous membranes.Perform a patch test before firstuse. lf irritation occurs,discontinue use.May increase sun sensitivityuse SPF.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)