IPKN MOIST AND FIRM BB 04 MEDIUM- titanium dioxide, octinoxate, octisalate, zinc oxide cream

IPKN Moist and Firm BB 04 Medium by

Drug Labeling and Warnings

IPKN Moist and Firm BB 04 Medium 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

Titanium Dioxide 10.05%

Octinoxate 7.00%

Octisalate 4.70%

Zinc Oxide 3.48%

PURPOSE

Sunscreen

INSTRUCTIONS FOR USE

For sunscreen use:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every two hours

- Use a water resistant sunscreen if swimming or sweating

ASK DOCTOR

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

INACTIVE INGREDIENT

Water

Cyclomethicone 5

Glycerin

Talc

Peg-10 dimethicone (600 cst)

Ferric oxide yellow

dipropylene glycol

hexyl laurate

isoeicosane

niacinamide

cyclomethicone

distearlydimonium

magnesium sulfate

ferric oxide red

c12 - 14 Pareth-3

phenoxyethanol

methicone (20 cst)

Aluminum hydroxide

aluminum stearate

palmitic acid

ferrosoferric oxide

betaine

ethylhexylglycerin

.alpha.-tocopherol acetate

treithoxycaprylylsilane

dimethicone

adenosine

polymethylsilsesquiopxane (4.5 microns)

ceramide 3

gold

butylene glycol

prunus serrulata flower

ethyl methane carboxamide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IPKN MOIST AND FIRM BB 04 MEDIUM  
titanium dioxide, octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.02 mg  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.88 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.392 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOEICOSANE (UNII: AR294KAG3T)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
DISTEARYLDIMONIUM (UNII: 251IW5I21C)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
C12-14 PARETH-3 (UNII: 93RY22U87E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
PALMITIC ACID (UNII: 2V16EO95H1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BETAINE (UNII: 3SCV180C9W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ADENOSINE (UNII: K72T3FS567)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CERAMIDE 3 (UNII: 4370DF050B)
GOLD (UNII: 79Y1949PYO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-109-02	1 in 1 CARTON	01/30/2018
1	NDC: 43526-109-01	40 mL 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(43526-109)