MAGIS LENE COLLAGEN CHOC EXTRA GOLD BB CREAM- ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream 
Inel Cosmetics Co., Ltd.

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.

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Drug Facts

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

Sunscreen

Helps prevent sunburn

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. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

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

Do not use on damaged or broken skin.

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

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

ML BB Cream - FDA

MAGIS LENE COLLAGEN CHOC EXTRA GOLD BB CREAM 
ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.305 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.96 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43526-113-021 in 1 CARTON01/30/2018
1NDC:43526-113-0150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/30/2018
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(43526-113)

Revised: 1/2018
Document Id: b14dd997-cec2-43d8-95d2-6aef3d488c0d
Set id: 9838123c-e69a-4f4b-aab5-a07c748600ed
Version: 3
Effective Time: 20180130
 
Inel Cosmetics Co., Ltd.