MAGIS LENE COLLAGEN CHOC EXTRA GOLD BB CREAM- ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream

Magis Lene Collagen Choc Extra Gold BB Cream by

Drug Labeling and Warnings

Magis Lene Collagen Choc Extra Gold BB Cream by is a Otc medication manufactured, distributed, or labeled by Inel Cosmetics Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate 3.00%
Titanium Dioxide 8.61%
Zinc Oxide 1.92%

PURPOSE

Sunscreen

Helps prevent sunburn

INSTRUCTIONS FOR USE

Apply liberally 15 minutes before sun exposure

Reapply at least every two hours

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m. - 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor.

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

ASK DOCTOR

Stop use and ask a doctor if rash occurs.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

DO NOT USE

Do not use on damaged or broken skin.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

WATER

CYCLOPENTASILOXANE

TALC

GLYCERIN

ISOEICOSANE

PEG-10 DIMETHICONE (600 CST)

MICA

ARBUTIN

DIPROPYLENE GLYCOL

CYCLOMETHICONE

TRIETHYLHEXANOIN

DISTEARDIMONIUM HECTORITE

HEXYL LAURATE

MAGNESIUM SULFATE

FERRIC OXIDE YELLOW

C12-14 PARETH-3

PHENOXYETHANOL

FERROSOFERRIC OXIDE

FERRIC OXIDE RED

METHICONE (20 CST)

PALMITIC ACID

METHYLPARABEN

TOCOPHERYL ACETATE

DIMETHICONE

BETAINE

PROPYLPARABEN

ALUMINUM HYDROXIDE

ADENOSINE

ALUMINUM STEARATE

BUTYLPARABEN

DIMETHICONE

PORK COLLAGEN

CERAMIDE 3

GOLD

PRUNUS SERRULATA FLOWER EXTRACT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAGIS LENE COLLAGEN CHOC EXTRA GOLD BB CREAM 
ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.5 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.305 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.96 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
ISOEICOSANE (UNII: AR294KAG3T)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICA (UNII: V8A1AW0880)
ARBUTIN (UNII: C5INA23HXF)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
C12-14 PARETH-3 (UNII: 93RY22U87E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
METHICONE (20 CST) (UNII: 6777U11MKT)
PALMITIC ACID (UNII: 2V16EO95H1)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
BETAINE (UNII: 3SCV180C9W)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PORK COLLAGEN (UNII: I8442U2G7J)
CERAMIDE 3 (UNII: 4370DF050B)
GOLD (UNII: 79Y1949PYO)
PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-113-02	1 in 1 CARTON	01/30/2018
1	NDC: 43526-113-01	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/30/2018

Labeler - Inel Cosmetics Co., Ltd. (688038939)

Registrant - Inel Cosmetics Co., Ltd. (688038939)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(43526-113)