AROCELL TONE UP PERFECT SUN- zinc oxide, titanium dioxide cream

AROCELL TONE UP PERFECT SUN by

Drug Labeling and Warnings

AROCELL TONE UP PERFECT SUN by is a Otc medication manufactured, distributed, or labeled by FICC Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AROCELL TONE UP PERFECT SUN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81647-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.82 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.84 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81647-070-02	1 in 1 CARTON	03/01/2021
1	NDC: 81647-070-01	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2021

Labeler - FICC Co., Ltd. (695721074)

Registrant - FICC Co., Ltd. (695721074)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(81647-070)