Label: AROCELL TONE UP PERFECT SUN- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81647-070-01, 81647-070-02 - Packager: FICC Co., Ltd.
- 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
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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
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other Information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AROCELL TONE UP PERFECT SUN
zinc oxide, titanium dioxide creamProduct 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)