BELUCIE LUXURY ESSENTIAL TWIN PACT NO21 SPF25 PA PLUS PLUS- titanium dioxide, octinoxate, zinc oxide powder

Belucie Luxury Essential Twin Pact NO21 by

Drug Labeling and Warnings

Belucie Luxury Essential Twin Pact NO21 by is a Otc medication manufactured, distributed, or labeled by KIMJEONGMOON ALOE CO., LTD., COSMAX INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide (CI 77891) 6.208%, Ethylhexyl Methoxycinnamate 4%, Zinc Oxide (CI 77947) 1.96%

INACTIVE INGREDIENT

Inactive Ingredients: Talc, Mica (CI 77019), Silica, Alumina, Methyl Methacrylate Crosspolymer, Ethylene/Acrylic Acid Copolymer, Triethylhexanoin, Hydrogenated Castor Oil Isostearate, Magnesium Myristate, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77492), Dimethicone, Triethoxycaprylylsilane, Methicone, Iron Oxides (CI 77491), Methylparaben, Iron Oxides (CI 77499), 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

Purpose: UVA/UVB Protection

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

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

Indication and usage
1. Recap the bottle after use.
2. Avoid exposure to a high or low temperature of direct sunlight

DOSAGE AND ADMINISTRATION

Dosage and administration
After take contents off puff, spread carefully depending on your skin texture.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BELUCIE LUXURY ESSENTIAL TWIN PACT NO21  SPF25 PA PLUS PLUS
titanium dioxide, octinoxate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50410-010
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: 50410-010-01	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(50410-010)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX INC.		689019313	manufacture(50410-010)