AROCELL TONE UP PERFECT SUN- zinc oxide, titanium dioxide cream 
FICC Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS

ZINC OXIDE 11.64%
TITANIUM DIOXIDE 3.68%

INACTIVE INGREDIENTS

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

Sunscreen

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps prevent sun burn

Directions

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

Other Information

■ Keep away from direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AROCELL TONE UP PERFECT SUN 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81647-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.82 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.84 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81647-070-021 in 1 CARTON03/01/2021
1NDC:81647-070-0150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2021
Labeler - FICC Co., Ltd. (695721074)
Registrant - FICC Co., Ltd. (695721074)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(81647-070)

Revised: 11/2022
Document Id: f09e38ad-eea5-4f8c-a4d5-cc37712ee298
Set id: 5c1929ed-a463-4524-9109-23bc2f92c6bc
Version: 2
Effective Time: 20221121
 
FICC Co., Ltd.