FDA.reportPublic FDA data

HYDRASPHERE PLUS

Manufacturer
HYDRASPHERE PLUS LLC
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:59:55

Label at a glance#

ProductHYDRASPHERE PLUS
Active ingredientRETINOL
Label structure11 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

active

OTC - ACTIVE INGREDIENT SECTION

RETINOL

inactive

INACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

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.

PREGAUTIONS:

OTC - DO NOT USE SECTION

Avoid contact with eyes ormucous membranes.

Directions for Use:

OTC - WHEN USING SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

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.

Directions for Use:

INDICATIONS & USAGE SECTION

Product Name:
HYDRASPHERE+ Anti Wrinkle Correction & Prevention

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

OTC - STOP USE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

picturepictureProduct 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85579-003-01HYDRASPHERE PLUS30 g in 1 BOTTLECREAM305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85579-003HYDRASPHERE PLUS (EYE CREAM) CREAM [HYDRASPHERE PLUS LLC]51 package rows20250430_33e7eeb9-70ba-5bfa-e063-6394a90afb78.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85579-00385579-003-01
84117-009

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM SILICATEIJF18F77L3IACT
WATER059QF0KO0RIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SODIUM POLYSTYRENE SULFONATE1699G8679ZIACT
CUCUMBER FRUIT OILR81Y52NPCTIACT
RHODIOLA ROSEA ROOT3S5ITS5ULNIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
SODIUM HYALURONATEYSE9PPT4THIACT
AVOCADO OIL6VNO72PFC1IACT
COFFEA ARABICA FRUITHOX6BEK27QIACT
TUBER MAGNATUM WHOLENHC4N42D3TIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
HESPERIDIN METHYL CHALCONE4T2GVA922XIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
HYALURONIC ACIDS270N0TRQYIACT
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE38H206R00RIACT
TREMELLA FUCIFORMIS WHOLE4938BNS0GUIACT
DIMETHYLAMINOETHANOL TARTRATED240J05W14IACT
RETINYL PALMITATE1D1K0N0VVCIACT
DIPEPTIDE-23G64B4AFQNIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
RETINOLG2SH0XKK91ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
54780041-94bd-c74e-e063-6294a90aa2d133e7eeb9-70ba-5bfa-e063-6394a90afb782026-06-17WarningsExact identifier
spl set id: 33e7eeb9-70ba-5bfa-e063-6394a90afb78

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.