FDA.reportPublic FDA data

Skin White Pro Strength Kojic and Hyaluronic Skin Lightening Serum

Manufacturer
Gazebo Wellness SKIN LLC
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:53

Label at a glance#

ProductSkin White Pro Strength Kojic and Hyaluronic Skin Lightening Serum
Active ingredientHYALURONIC ACID, GLYCOLIC ACID, LACTIC ACID, NIACINAMIDE, KOJIC ACID, ALPHA-ARBUTIN, ASCORBIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

WARNINGS SECTION

Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Organic Coconut Oil, Grapeseed Oil, Emulsifying Wax, Stearic Acid, Glycerin, Xanthan Gum, Propylene Glycol, Undecylenoyl Phenylalanine, Phenoxyethanol, Tetrasodium Glutamate Diacetate.

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Magnesium Ascorbyl Phosphate, Niacinamide B3, Glycolic Acid, Lactic Acid, Hyaluronic Acid, Kojic Acid, Alpha Arbutin, Hydrolyzed Oat Protein, Ethyl Ascorbic Acid, DL-Alpha Tocopherol (Vitamin E).

INDICATIONS & USAGE SECTION

Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

OTC - PURPOSE SECTION

Pro Strength Treatment
Skin White
Fade & Remove Dark Spots, Melasma, Acne Scars, & More
Formulated with Kojic Acid, Alpha Arbutin, Lactic Acid, Glycolic Acid, Ferulic Acid, Vitamin B3 + C + E

Distributed By: Skin Beauty Solutions Elk Grove CA 95759
MADE NUSA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Content of labeling

Content of labeling 2oz 60 mlContent of labeling 2oz 60 mlContent of labeling 4oz 60 mlContent of labeling 4oz 60 ml

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84785-0010SKIN WHITE PRO STRENGTH KOJIC AND HYALURONIC SKIN LIGHTENING SERUM SOLUTION [GAZEBO WELLNESS SKIN LLC]2Unmatched20241218_23d47d29-76c1-9c05-e063-6394a90acd24.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84785-001084785-0010-1, 84785-0010-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
PROPYLENE GLYCOL DIACETATE5Z492UNF9OIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
HYALURONIC ACIDS270N0TRQYACTIB
GLYCOLIC ACID0WT12SX38SACTIB
LACTIC ACID33X04XA5ATACTIB
NIACINAMIDE25X51I8RD4ACTIB
COCONUT OILQ9L0O73W7LIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYLALANINE47E5O17Y3RIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
KOJIC ACID6K23F1TT52ACTIB
ALPHA-ARBUTIN72VUP07IT5ACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
WATER059QF0KO0RIACT

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
4008ebbe-042b-e7cd-e063-6294a90a957023d47d29-76c1-9c05-e063-6394a90acd242025-09-30WarningsExact identifier
spl set id: 23d47d29-76c1-9c05-e063-6394a90acd24

Reported adverse events (FAERS/openFDA)#

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