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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 21, 2022

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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

  • INGREDIENTS AND APPEARANCE
    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)
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