Label: BELUCIE LUXURY ESSENTIAL TWIN PACT NO23 SPF25 PA PLUS PLUS- titanium dioxide, octinoxate, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 50410-020-01 - Packager: KIMJEONGMOON ALOE CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 28, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Talc, Mica (CI 77019), Silica, Alumina, Methyl Methacrylate Crosspolymer, Ethylene/Acrylic Acid Copolymer, Triethylhexanoin, Zinc Oxide (CI 77947), Hydrogenated Castor Oil Isostearate, Magnesium Myristate, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77492), Dimethicone, Triethoxycaprylylsilane, Methicone Iron Oxides (CI 77491), Iron Oxides (CI 77499), Methylparaben, Fragrance(Parfum), Butylparaben, Acorus Gramineus Root/Stem Extract, Ultramarines (CI 77007), Morus Alba Bark Extract, Water, Butylene Glycol, Bacillus/Soybean Ferment Extract, Polyperfluoromethylisopropyl Ether, Aloe Barbadensis Leaf Extract, Chrysanthellum Indicum Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Nelumbo Nucifera Flower Extract, Carthamus Tinctorius (Safflower) Flower Extract, Laminaria Saccharina Extract, Glycerin, Camellia Sinensis Leaf Extract, Angelica Keiskei Leaf/Stem Extract, Rubus Suavissimus (Raspberry) Leaf Extract, Glycine Soja (Soybean) Oil, Lecithin, Alcohol Denat., Human Oligopeptide-1
- 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 dematologists.
2. In case of having problems such as red spots, swelling, itching and irritation during usage
3. In case the above symptoms emerge due to direct exposure to sunlight
4. Please do not apply the skin to areas affected by eczema and dermatitis - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BELUCIE LUXURY ESSENTIAL TWIN PACT NO23 SPF25 PA PLUS PLUS
titanium dioxide, octinoxate, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50410-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.744 g in 12 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.48 g in 12 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.235 g in 12 g Inactive Ingredients Ingredient Name Strength Talc (UNII: 7SEV7J4R1U) Mica (UNII: V8A1AW0880) Triethylhexanoin (UNII: 7K3W1BIU6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50410-020-01 12 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2012 Labeler - KIMJEONGMOON ALOE CO., LTD. (689253722) Registrant - KIMJEONGMOON ALOE CO., LTD. (689253722) Establishment Name Address ID/FEI Business Operations KIMJEONGMOON ALOE CO., LTD. 689253722 repack(50410-020) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689019313 manufacture(50410-020)
