Label: 3 CONCEPT EYES BACK TO BABY- titanium dioxide, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60764-011-01 - Packager: NANDA 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 February 5, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water,Cyclopentasiloxane, Butylene Glycol, Phenyl Trimethicone, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Zinc Oxide (CI 77947), Niacinamide, Sodium Chloride, Cyclomethicone, Glycerin, Disteardimonium Hectorite, Pentylene Glycol, Iron Oxides (CI 77492), Glyceryl Behenate/Eicosadioate, Sorbitan Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Methyl Methacrylate Crosspolymer, Phenoxyethanol, Dimethicone Crosspolymer, Iron Oxides (CI 77491), Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Fragrance(Parfum), Acrylates/Dimethicone Copolymer, Dimethicone, Disodium EDTA,Ethylhexylglycerin, Adenosine, Sodium Hyaluronate, Pearl Powder, Amethyst Powder, Tourmaline, Diamond powder, Coral Powder, Portulaca Oleracea Extract, Methylparaben
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
3 CONCEPT EYES BACK TO BABY
titanium dioxide, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 2.90 mg in 30 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60764-011-01 30 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 Labeler - NANDA CO., LTD. (557816075) Registrant - NANDA CO., LTD. (557816075) Establishment Name Address ID/FEI Business Operations NANDA CO., LTD. 557816075 manufacture(60764-011)
