Label: LUMINOUS GODDESS AURA BB- titanium dioxide, octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-042-01 - 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 February 27, 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, Magnesium Sulfate, Sorbitan Sesquioleate, Silica, Iron Oxides (CI 77492), Disteardimonium Hectorite, Isoamyl p-Methoxycinnamate, Tribehenin, Iron Oxides (CI 77491), Aluminum Hydroxide, Methylparaben, Chlorphenesin, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Iron Oxides (CI 77499), Stearic Acid, Triethoxycaprylylsilane, Glyceryl Behenate, Calcium Stearate, Polyglyceryl-6 Octastearate, Propylparaben, Fragrance(Parfum), Dimethicone, Disodium EDTA, Butylene Glycol, Adenosine, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Coral, Borago Officinalis Seed Oil, Bertholletia Excelsa Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Argania Spinosa Kernel Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Centella Asiatica Extract, Caffeine, Hydrolyzed Collagen, Rosa Damascena Flower Oil, Rosa Gallica Flower Extract, Camellia Sinensis Leaf Extract, Arnica Montana Flower Extract, Jasminum Officinale (Jasmine) Flower Extract, Portulaca Oleracea Extract, Achillea Millefolium Extract, Pearl Powder, Dipeptide Diaminobutyroyl Benzylamide Diacetate, Sodium Hyaluronate, Palmitoyl Tripeptide-5
- PURPOSE
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WARNINGS
Warnings: 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.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LUMINOUS GODDESS AURA BB
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-042 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:59078-042-01 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(59078-042) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689019313 manufacture(59078-042)
