IPKN MOIST AND FIRM BB 01 FAIR- titanium dioxide, octinoxate, octisalate, 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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43526-111_Deactivation

Titanium Dioxide 10.05%

Octinoxate 7%

Octisalate 4.7%

Zinc Oxide 3.48%

Sunscreen

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

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

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

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

ehyl methane carboxamide

image description

IPKN MOIST AND FIRM BB 01 FAIR
titanium dioxide, octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43526-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOEICOSANE (UNII: AR294KAG3T)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE (UNII: NMQ347994Z)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
C12-14 PARETH-3 (UNII: 93RY22U87E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITIC ACID (UNII: 2V16EO95H1)
BETAINE (UNII: 3SCV180C9W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
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)
RICE OIL (UNII: ACU8G2V809)
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43526-111-02	1 in 1 CARTON	01/30/2018	12/06/2021
1	NDC:43526-111-01	40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/30/2018	12/06/2021

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co., Ltd.		689512611	manufacture(43526-111)

Revised: 12/2021

Document Id: d282404b-298f-316d-e053-2995a90aea2c

Set id: a6ab2d73-225e-4884-97b8-9614e8ce599e

Version: 6

Effective Time: 20211206

Inel Cosmetics Co., Ltd.