FDA.reportPublic FDA data

AROCELL VITA20 POWER

Manufacturer
FICC Co., Ltd. | Cosmax, Inc.
Effective date
2021-03-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:48:27

Label at a glance#

ProductAROCELL VITA20 POWER
Active ingredientDimethicone
Label structure9 sections

Indications and uses

■ Helps protect your skin. ■ Helps brighten skin tone.

Dosage and administration

■ Apply evenly onto areas with uneven pigmentation. ■ Replace the cover after use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 9.0%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Ascorbic Acid (20%), Cetyl Ethylhexanoate, Hydrogenated Vegetable Oil, Triethylhexanoin, Paraffin, Phenyl Trimethicone, Polyethylene, Diisostearyl Malate, Olea Europaea (Olive) Fruit Oil, Polymethylsilsesquioxane, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Glycyrrhiza Glabra (Licorice) Root Extract, Silica Silylate, Sorbitan Isostearate, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Cera Microcristallina (EU), Caprylyl Glycol, Fragrance (Parfum)

PURPOSE

OTC - PURPOSE SECTION

Skin protectant

WARNINGS

WARNINGS SECTION

For external use only
Consult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.
Avoid using on wounded areas.
Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

■ Helps protect your skin.
■ Helps brighten skin tone.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply evenly onto areas with uneven pigmentation.
■ Replace the cover after use.

Other Information

OTHER SAFETY INFORMATION

■ Keep away from direct sunlight.
■ The formulation may soften at a temperature of 113°f or higher, but the content is still safe for use.
■ Recommend using at night prior to sleep.
■ Ascorbic acid (20%) may cause irritation for those with sensitive skin. To prevent possible irritation, apply as the final step of skin care routine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81647-100-022023-12-05C16284748780-1f386c64a-04e0-0266-e053-dadaa90a7c1a0948df9e-aaa2-4baa-a2a0-c4ed87fb827a
81647-100-022023-01-30C16284748780-1f386c64a-04e0-0266-e053-dadaa90a7c1a0948df9e-aaa2-4baa-a2a0-c4ed87fb827a

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81647-10081647-100-01, 81647-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
Cetyl Ethylhexanoate134647WMX4IACT
Triethylhexanoin7K3W1BIU6KIACT

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
32de447b-98a1-4a73-9618-b602e0ebdd150948df9e-aaa2-4baa-a2a0-c4ed87fb827a2023-12-05WarningsExact identifier
spl set id: 0948df9e-aaa2-4baa-a2a0-c4ed87fb827a

Reported adverse events (FAERS/openFDA)#

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