FDA.reportPublic FDA data

AROCELL TONE UP PERFECT SUN

Manufacturer
FICC Co., Ltd. | Cosmax, Inc.
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:43

Label at a glance#

ProductAROCELL TONE UP PERFECT SUN
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

■ Helps prevent sun burn

Dosage and administration

■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 11.64%
TITANIUM DIOXIDE 3.68%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cyclomethicone, Dicaprylyl Carbonate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Ethylhexyl Palmitate, Caprylyl Methicone, Diphenylsiloxy Phenyl Trimethicone, Dipropylene Glycol, Niacinamide, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Calamine, Polyhydroxystearic Acid, Disteardimonium Hectorite, Sodium Chloride, Triethoxycaprylylsilane, Aluminum Hydroxide, Synthetic Beeswax, Caprylic/Capric Triglyceride, Stearic Acid, Caprylyl Glycol, Fragrance(Parfum), Glyceryl Caprylate, C12-15 Alkyl Benzoate, Adenosine, Polyglyceryl-2 Triisostearate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Tocopherol, Isostearic Acid, Citrus Junos Fruit Oil, Polymethyl Methacrylate, Polyvinyl Alcohol

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

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 prevent sun burn

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

Other Information

OTHER SAFETY INFORMATION

■ Keep away from direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81647-070-022024-01-30C16284748780-11030e365-2896-111a-e063-dadaa90a10e25c1929ed-a463-4524-9109-23bc2f92c6bc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81647-070-01AROCELL TONE UP PERFECT SUN50 g in 1 TUBECREAM502
81647-070-02AROCELL TONE UP PERFECT SUN1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81647-070AROCELL TONE UP PERFECT SUN (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [FICC CO., LTD.]2Legacy NDC, 2 package rows20221122_5c1929ed-a463-4524-9109-23bc2f92c6bc.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81647-07081647-070-01, 81647-070-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOMETHICONENMQ347994ZIACT
Dicaprylyl Carbonate609A3V1SUAIACT
GlycerinPDC6A3C0OXIACT

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
f09e38ad-eea5-4f8c-a4d5-cc37712ee2985c1929ed-a463-4524-9109-23bc2f92c6bc2022-11-21WarningsExact identifier
spl id: f09e38ad-eea5-4f8c-a4d5-cc37712ee298
spl set id: 5c1929ed-a463-4524-9109-23bc2f92c6bc

Reported adverse events (FAERS/openFDA)#

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