SPL v2
SPL
SPL Set ID ef645411-b9da-4e3a-9bf7-8c2fb6ee80ee
Route
TOPICAL
Published
Effective Date 2009-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arbutin (1 mL) Dimethicone (2 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-11-01
Description

ACTIVE INGREDIENTS: Dimethicone, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Stearyl Glycyrrhetinate

Medication Information

Description

ACTIVE INGREDIENTS: Dimethicone, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Stearyl Glycyrrhetinate

Section 50565-1

Caution: For external use only.  Keep out of reach of children.  Discontinue use if irritation occurs.

Section 50567-7

DIRECTION OF USE:

After using Fortifier(essence) take an appropriate amount of cream using the enclosed spoon and gently spread on face as if massaging.  Tap lightly for absorption.  For better results, use with whitening Fortifier.

Section 51945-4


Label4c





Section 55106-9

ACTIVE INGREDIENTS:

Dimethicone, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Stearyl Glycyrrhetinate

Structured Label Content

Section 50565-1 (50565-1)

Caution: For external use only.  Keep out of reach of children.  Discontinue use if irritation occurs.

Section 50567-7 (50567-7)

DIRECTION OF USE:

After using Fortifier(essence) take an appropriate amount of cream using the enclosed spoon and gently spread on face as if massaging.  Tap lightly for absorption.  For better results, use with whitening Fortifier.

Section 51945-4 (51945-4)


Label4c





Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Dimethicone, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Stearyl Glycyrrhetinate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:58.369110 · Updated: 2026-03-14T22:52:13.708968