Label: TONYMOLY LUMINOUS GODDESS AURA BB 02- titanium dioxide, octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-052-01 - Packager: Tonymoly 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 March 3, 2015
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Hexyldecyl Myristoyl Methylaminopropionate, Hexyl Laurate, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Magnesium Sulfate, Phenoxyethanol, Disteardimonium Hectorite, Isoamyl p-Methoxycinnamate, Silica, Iron Oxides (CI 77491), Tribehenin, Iron Oxides (CI 77499), Aluminum Hydroxide, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Stearic Acid, Triethoxycaprylylsilane, Glyceryl Behenate, Calcium Stearate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone, Disodium EDTA, Adenosine, Water, Butylene Glycol, Ceramide 3, Tremella Fuciformis (Mushroom) Extract, Mica (CI 77019), Glycerin, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Ethyl Hexanediol, Oxygen
- PURPOSE
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WARNINGS
Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TONYMOLY LUMINOUS GODDESS AURA BB 02
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 4.47 g in 45 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3.15 g in 45 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.32 g in 45 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Dipropylene Glycol (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-052-01 45 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2014 Labeler - Tonymoly Co., Ltd. (688216798) Registrant - Tonymoly Co., Ltd. (688216798) Establishment Name Address ID/FEI Business Operations Tonymoly Co., Ltd. 688216798 repack(59078-052) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689019313 manufacture(59078-052)