85004-001

85004-001
SPL v1
SPL
SPL Set ID 2ff89a13-3969-2df1-e063-6394a90ac0d3
Route
CUTANEOUS
Published
Effective Date 2025-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Squalane (0.15 g) Trehalose (0.4116 g) Hydrogenated Polybutene (1300 Mw) (25.8 g) Niacinamide (2.1 g)
Inactive Ingredients
Lithospermum Erythrorhizon Root Allantoin Tocopherol Ceramide Ap Ethylhexyl Palmitate Ci 61565 Alpha-tocopherol Acetate Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Ci 60725 Limnanthes Alba (meadowfoam) Seed Oil Edetate Disodium Ceramide Ns Ascorbyl Tetraisopalmitate Ethylhexylglycerin Ethoxydiglycol Sodium Hyaluronate Sodium Butyroyl/formoyl Hyaluronate 1,2-hexanediol Panthenol Simmondsia Chinensis (jojoba) Seed Oil Argania Spinosa Kernel Oil 3-o-ethyl Ascorbic Acid Dipotassium Glycyrrhizate Ascorbyl Palmitate Ceramide Np Ci 73360 Pentylene Glycol Aqua C15-19 Alkane Glycerin Butylene Glycol Methyl Gluceth-20 Magnesium Sulfate Sodium Acetylated Hyaluronate Hydroxyethylcellulose Hydrogenated Soybean Lecithin Hydroxyacetophenone Camellia Japonica Flower Xanthan Gum Sodium Carboxymethyl .beta.-glucan (ds 0.65-0.85) Phosphatidylcholine, Soybean Lactobacillus Adenium Obesum Leaf Ascorbyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-10

Description

NIACINAMIDE 2.1% SQUALANE 0.15% TREHALOSE 0.4116% HYDROGENATED POLYISOBUTENE 25.8%

Purpose

Whitening Agent Repair Moisturizing agent Moisturizer


Medication Information

Purpose

Whitening Agent

Repair

Moisturizing agent

Moisturizer



Description

NIACINAMIDE 2.1% SQUALANE 0.15% TREHALOSE 0.4116% HYDROGENATED POLYISOBUTENE 25.8%

Use

shake well before use, take an appropriate amount of the

product and apply it evenly to the facial skin. Gently massage

until absorbed.



Section 50565-1

If accidentally swallowed, please seek medical attention.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.



Section 50567-7

When using this product, if it accidentally gets into the eyes, please rinse thoroughly with water and keep out of reach of

children.



Warnings

It is recommended to try it locally behind the ear before initial use; If you experience any discomfort during

use, please stop using immediately.This product is for external use.



Directions

Apply proper amount of whitening and spot lightening essence evenly on the face, which can be gently massaged to help absorb

Do Not Use

OPEN SKIN WOUND



Other Information

Please keep in a cool and dry place, away from sunlight and high temperatures.



Active Ingredient(s)

NIACINAMIDE 2.1%

SQUALANE 0.15%

TREHALOSE 0.4116%

HYDROGENATED POLYISOBUTENE 25.8%



Inactive Ingredients

AQUA、C15-19 ALKANE、GLYCERIN BUTYLENE GLYCOL METHYL GLUCETH-20、MAGNESIUM SULFATE、

1,2- HEXANEDIOL、HYDROXYACETOPHENONE PANTHE-NOL、LIMNANTHES ALBA (MEADOWFOAM) SEED OIL、

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、ARGANIA SPINOSA KERNEL OIL、CAMELLIA JAPONICA FLOWER

EXTRACT、SODIUM HYALURONATE、3-0- ETHYL ASCORBIC ACID、ALLANTOIN LITHOSPERMUM ERYTHRORHIZON

ROOT EXTRACT、XANTHAN GUM、ASCORBYL TETRAISOPALMITATE、DIPOTASSIUM GLYCYRRHIZATE、

ASCORBYL GLUCOSIDE、PENTYLENE GLYCOL、TOCOPH-EROL、ADENIUM OBESUM LEAF CELL EXTRACT、HYDRO-

LYZED SODIUM HYALURONATE、LACTOBACILLUS/SOYM-ILK FERMENT FILTRATE、ETHYLHEXYL

PALMITATE、BETA-GLUCAN、 SODIUM ACETYLATED HYALURONATE、TOCOPHERYL ACETATE、SODIUM

HYALURONATE CROSSPOLYMER、HYDROXYETHYLCELL-ULOSE、HYDROGENATED LECTTHIN、

ASCORBYL PALMIT-ATE CERAMIDE NS/CERAMIDE NG、CERAMIDENP、 CER-AMIDE AP、CI 73360、ETHYLHEXYLGLYCERIN、DISODIUM EDTA、PHOSPHATIDYLCHOLINE、 CI 61565、CI 60725、ETHOXYDIGLYCOL

Package Label Principal Display Panel


Structured Label Content

Use

shake well before use, take an appropriate amount of the

product and apply it evenly to the facial skin. Gently massage

until absorbed.



Section 50565-1 (50565-1)

If accidentally swallowed, please seek medical attention.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.



Section 50567-7 (50567-7)

When using this product, if it accidentally gets into the eyes, please rinse thoroughly with water and keep out of reach of

children.



Purpose

Whitening Agent

Repair

Moisturizing agent

Moisturizer



Warnings

It is recommended to try it locally behind the ear before initial use; If you experience any discomfort during

use, please stop using immediately.This product is for external use.



Directions

Apply proper amount of whitening and spot lightening essence evenly on the face, which can be gently massaged to help absorb

Do Not Use (Do not use)

OPEN SKIN WOUND



Other Information (Other information)

Please keep in a cool and dry place, away from sunlight and high temperatures.



Active Ingredient(s)

NIACINAMIDE 2.1%

SQUALANE 0.15%

TREHALOSE 0.4116%

HYDROGENATED POLYISOBUTENE 25.8%



Inactive Ingredients (Inactive ingredients)

AQUA、C15-19 ALKANE、GLYCERIN BUTYLENE GLYCOL METHYL GLUCETH-20、MAGNESIUM SULFATE、

1,2- HEXANEDIOL、HYDROXYACETOPHENONE PANTHE-NOL、LIMNANTHES ALBA (MEADOWFOAM) SEED OIL、

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、ARGANIA SPINOSA KERNEL OIL、CAMELLIA JAPONICA FLOWER

EXTRACT、SODIUM HYALURONATE、3-0- ETHYL ASCORBIC ACID、ALLANTOIN LITHOSPERMUM ERYTHRORHIZON

ROOT EXTRACT、XANTHAN GUM、ASCORBYL TETRAISOPALMITATE、DIPOTASSIUM GLYCYRRHIZATE、

ASCORBYL GLUCOSIDE、PENTYLENE GLYCOL、TOCOPH-EROL、ADENIUM OBESUM LEAF CELL EXTRACT、HYDRO-

LYZED SODIUM HYALURONATE、LACTOBACILLUS/SOYM-ILK FERMENT FILTRATE、ETHYLHEXYL

PALMITATE、BETA-GLUCAN、 SODIUM ACETYLATED HYALURONATE、TOCOPHERYL ACETATE、SODIUM

HYALURONATE CROSSPOLYMER、HYDROXYETHYLCELL-ULOSE、HYDROGENATED LECTTHIN、

ASCORBYL PALMIT-ATE CERAMIDE NS/CERAMIDE NG、CERAMIDENP、 CER-AMIDE AP、CI 73360、ETHYLHEXYLGLYCERIN、DISODIUM EDTA、PHOSPHATIDYLCHOLINE、 CI 61565、CI 60725、ETHOXYDIGLYCOL

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)