IPKN MOIST AND FIRM BB 05 MEDIUM TAN- titanium dioxide, octinoxate, octisalate, zinc oxide cream

IPKN MOIST AND FIRM BB 05 MEDIUM TAN by

Drug Labeling and Warnings

IPKN MOIST AND FIRM BB 05 MEDIUM TAN 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

If rash or irritation occurs, stop use and ask a doctor.

WHEN USING

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

INACTIVE INGREDIENT

WATER
CYCLOPENTASILOXANE
GLYCERIN
IRON OXIDES(CI77492)
PEG-10 DIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
ISOEICOSANE
NIACINAMIDE
CYCLOMETHICONE
TALC
DISTEARDIMONIUM HECTORITE
IRON OXIDES(CI77491)
MAGNESIUM SULFATE
IRON OXIDES(CI77499)
C12-14 PARETH-3
ACRYLATES/DIMETHICONE COPOLYMER
PHENOXYETHANOL
METHICONE
ALUMINUM HYDROXIDE
ALUMINUM STEARATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
PALMITIC ACID
TRIETHOXYCAPRYLYLSILANE
BETAINE
ETHYLHEXYLGLYCERIN
FRAGRANCE
TOCOPHERYL ACETATE
DIMETHICONE
ADENOSINE
AMINOPROPYL DIMETHICONE
POLYMETHYLSILSESQUIOXANE
CERAMIDE 3
COLLAGEN
GOLD
BUTYLENE GLYCOL
ONSEN-SUI
PRUNUS SERRULATA FLOWER EXTRACT
RICE FERMENT FILTRATE (SAKE)
MENTHYL PCA
ETHYL MENTHANE CARBOXAMIDE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IPKN MOIST AND FIRM BB 05 MEDIUM TAN 
titanium dioxide, octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.2 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 CATION - UNII:13S1S8SF37)	ZINC CATION	1.52 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CERAMIDE NP (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)
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)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
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)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PALMITIC ACID (UNII: 2V16EO95H1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BETAINE (UNII: 3SCV180C9W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ADENOSINE (UNII: K72T3FS567)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-121-02	1 in 1 CARTON	01/31/2018
1	NDC: 43526-121-01	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	01/31/2018

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(43526-121)